chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe stomach cramp; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach cramp) and DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome (Occasion IBS like symptoms but not constantly).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach cramp) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach cramp) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included loperamide.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Headache - seeing "stars", legs painful and hurt to walk - inner legs painful. (L) underarm pain and swelling - minor groin pain.
Started w/slight dizziness next day that increased during day. At 3 am awaken from sleep w/extreme vertigo/non- stopped vomiting for a few hours. Zofran from doctor stopped vomiting.  Excessive sweating chills  and hot flashes   But no fever.  Could not walk on own for 24 hours. Still experiencing dizziness if stand up or bend over too fast.  Ringing in ears.
I had aches, fever, difficulty breathing, congestion, nausea, wheezing, headache, sinus pressure, sore throat, ulcers on my tongue, fatigue. These symptoms are still happening but not as severe as the first week. I had difficultly getting out of bed and was unable to work. It was horrible. I self -cared at home. I took Paxlovid.
When the injection was placed I experienced deep pain inside my shoulder. Within 3 hours my shoulder was frozen in pain and unable to move. I used ice and anti-inflammatory medication with no relief. I was unable to move my shoulder and could not complete daily self care tasks like brushing hair, changing clothes, cooking or driving. I could not drive to work the next day and had to use sick leave. I was in a high level of pain. I woke up crying throughout the night for three nights due to pain. I sought care at unspecified Urgent Care and was told that it was just sore and I need to keep moving the shoulder and apply heat. I was given an RX for Cephalexin, an antibiotic. Dr. indicated the injection site was warm to the touch. By Wednesday morning, there has been a slight improvement in pain and mobility. I am able to hold my arm straight down as opposed to keeping the elbow bent and tucked in. Still cannot raise my arm at all from the shoulder joint.
Information has been received from a registered nurse concerning a 19 year old female student (63 inches, 112 lbs) with no illness at the time of vaccination and with a penicillin allergy. On 01-FEB-2007, at approximately 14:00 PM, the patient was vaccinated in the left arm with the first 0.5 mL dose of HPV (lot# 655619/1427F). Concomitant therapy included Yasmin. On that same day, at 4:00 PM, the patient developed a rash on her left arm from the injection site to the elbow and a rash also on her right arm (unspecified where on her right arm). The patient sought unspecified medical attention. The physician prescribed over-the-counter Benadryl and contacted the patient the next day for follow up. The patient reported that she was fine. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.  Additional infromation is not expected.
Around 12 pm there were several hives that appeared on the right side of my body. They appeared on my right wrist, arm, thigh, calf, and ankle. I am allergic to Benedryl so I did not take anything besides Acetaminophen to calm down the pain and swelling in my arm.
Area has been hurting; Upper respiratory infection; Feel shaky; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received the 2nd dose of Shingles vaccine. In December 2022, between 2 and 3 weeks after receiving Shingles vaccine, the patient experienced injection site pain, upper respiratory tract infection and shaky feelings. On an unknown date, the outcome of the injection site pain, upper respiratory tract infection and shaky feelings were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, upper respiratory tract infection and shaky feelings to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-DEC-2022. Reporter's Comment: This case was received from consumer via interactive digital media. The reporter stated that the patient took second shingles shot about 3 weeks ago and for about a week now the area has been hurting and had feeling like the patient had a upper respiratory infection and the patient feel shaky. The reporter want to known could this be a side effect from the vaccine. The follow up would not possible, as no contact details were available.
Red irritated area on right arm where varicella was given. Bruised round knot on left arm were MENACTRA was given.
No additional AEs; The physician reported that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (w017571   11/29/2023) Temperature: 10.1F  Time frame; This spontaneous report was received from a physician and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, lot number w017571, expiration date: 29-NOV-2023, administered for prophylaxis (exact dose, strength, and route of administration were not provided). It was reported that before administration, the vaccine was improperly stored (temperature: 10.1 Fahrenheit, time frame: 51 hours, no previous temperature excursion) (product storage error). No additional adverse events reported (no adverse event).
Poor Quality drug Administered; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA AC) injection for Crohns disease aggravated.    Concurrent medical conditions included Alcohol use (Variety, once a week) since 2012, Tobacco user (one cigarette every 2 weeks) since 2014 and Autistic disorder. Concomitant products included ESTRADIOL and SPIRONOLACTONE for Gender reassignment therapy.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA AC) (Subcutaneous) 40 mg once a week. On 08-Jun-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) 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 POOR QUALITY PRODUCT ADMINISTERED (Poor Quality drug Administered) to have an unknown relationship.    No treatment information was provided by the reporter.
Approximately two hours after receiving the second dose of the COVID-19 vaccine, the patient complained of shortness of breath, feeling flushed, throat burning, tongue swelling and numbness, elevated heart rate, diaphoresis, dry mouth, weakness, and reddened skin. Patient was still in the facility where he received the vaccine and was immediately taken to the Emergency Department. The patient received Pepcid 20 mg by mouth, Benadryl 25 mg by mouth, and Predisone 40 mg by mouth.
extreme vertigo; Could not stand up or sit up for most of that day and Tuesday the 7th of September.; chills; body aches; fever; some fatigue; feeling a bit out of balance; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 12:00 (Lot number: FD8448) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? Yes. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 01Sep2021 21:00, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 01Sep2021 21:00, outcome "not recovered", described as "body aches"; PYREXIA (non-serious) with onset 01Sep2021 21:00, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 01Sep2021 21:00, outcome "not recovered", described as "some fatigue"; VERTIGO (non-serious) with onset 06Sep2021, outcome "recovered" (Sep2021), described as "extreme vertigo"; DYSSTASIA (non-serious) with onset 06Sep2021, outcome "not recovered", described as "Could not stand up or sit up for most of that day and Tuesday the 7th of September."; BALANCE DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "feeling a bit out of balance". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain, pyrexia, fatigue, vertigo, dysstasia, balance disorder.  Additional Information: It was reported that the patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered at workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19, prior to vaccination. The patient has been tested for COVID-19 since having the vaccination. Patient stated that the vertigo continues most mornings but was gone mostly by the time patient finished my shower. There are periods during most days when patient do find himself feeling a bit out of balance. Patient had never experienced vertigo or been diagnosed with vertigo before. Case was reported as non serious. Hospitalization Prolonged was reported as no.  No follow-up attempts are possible. No further information is expected.
Pt c/o headache starting several hours after vaccine was given. Stated pain was a ?7? on a scale of 1-10, 10 being the worst.  Relieved by 400 mg  ibuprofen. Woke up next morning with h/a also relieved by 400 mg ibuprofen.
3 days after received flu vaccine patient experienced reddened area that was hot and itchy that measured about 2" across.
Patient was fully vaccinated when he tested positive for COVID-19 on 8/15/21.
Patient stated: started having a reaction that night upon receiving vaccine. started out as a small red, itchy circle about the size of a quarter. Today (4/20/22), the area is about 6-7 in in diameter still itchy and red. Has continued to grow in size. Patient has tried ice packs and tylenol.  I suggested trying benadryl, ice packs and a steroid cream. Told patient to contact her doctor in the morning to discuss the adverse reaction.
28MAR92 pt exp severe h/a, palpitations, & difficulty breathing; pt exp episodes of rapid heart beat, weakness, lightheadedness, nausea, & SOB; pt exp tight feeling in throat, chills, ached all over, ringing in ears, swollen lymph glands;
Pt recv vax on 11/6/97; 5 hr later pt exp rash & itching behind knees &trunk; tx=Benadryl; pt imp 45 min.
Vaccine administered 9/24/13 - Pt reported blood blisters on tongue, gums, inside cheeks of mouth and petechia all over body on 9/25/13. 9/26/13 stated improving.
At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent reporting for son (patient).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine".  Additional information: Developed an allergy to ibuprofen. Every time reporter take ibuprofen reporter develop "hives". Reporter get small, red circular bumps that are extremely itchy. At first reporter thought reporter might just be allergic to a dye in the tablets but the son (patient) developed the same type of reaction after receiving his first covid vaccine (and he takes a different brand of ibuprofen).  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.
large area swelling arm 3 weeks after injection at injection site - 3x4cm size requiring oral steroids, Ibuprofen & antihistamines for reaction
nausea, vomiting, temp to 103, hypotension starting 102hr p/vax;required hosp;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 11-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 23Nov2022, outcome "not recovered", described as "light headache"; CONDITION AGGRAVATED (non-serious) with onset 24Nov2022, outcome "not recovered", described as "Symptoms started on Thursday and it is getting progressively worse"; DIZZINESS (non-serious) with onset 24Nov2022, outcome "not recovered", described as "constant dizziness"; FEELING ABNORMAL (non-serious) with onset 24Nov2022, outcome "not recovered", described as "memory fog"; MUSCULAR WEAKNESS (non-serious) with onset 24Nov2022, outcome "not recovered", described as "weakness in her hands"; HEAD DISCOMFORT (non-serious), outcome "not recovered", described as "a constant pressure that had not stopped, like her head was about to open". The events "weakness in her hands", "light headache", "constant dizziness", "memory fog" and "a constant pressure that had not stopped, like her head was about to open" required physician office visit. Therapeutic measures were taken as a result of muscular weakness, headache, dizziness, feeling abnormal, head discomfort.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Chills and fever ranging from 99-102.7 for 48 hours, fatigue and muscle soreness persisting for four days post injection, headache, post nasal drip/sore throat from day 3-4
Starting on April 9,2021 I felt a deep pain in my right shoulder, like bone pain, extremely painful.  Nothing relieved the pain which still continues as of today. I spoke with my sister yesterday and she told me that she read that should pain was one of the adverse reactions and sent me a copy of the statement. I have not gone to my PCP as I thought it was normal even though the pain is almost unbearable.  I am going to email him this evening so he is aware of issue.
Patient has had chest pain, Dyspnea and headaches since receiving COVID vaccination.  States that sx's increased after 2nd dose
Noticed 3 weeks & 2 days post 2nd dose of moderna erythema dry papulas on torso (front, back, anticubicals) with 2 satellite lesions on arms. Non itchy, no improvement with topical steroid, oral antihistamines, or topical antifungal still occurring 5 days later.
Rash on left upper arm started Friday, 4/10/15. Seen at Emergency Room on 4/12/15 with continued itching.
No adverse events reported. Patient given extra dose HIB vaccine. Parent called next day to report error.  Mom stated patient well with no issues.
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. The patient was vaccinated with GARDASIL, intramuscularly (lot# and dose unspecified) on 08-MAY-2013, 06-JUN-2013 and on 29-AUG-2013. No known adverse effects. It was unspecified whether the patient sought for medical attention. Additional information has been requested.
Reporting administration error.  Patient is immunosuppressed and nursing staff was new and failed to follow protocol and administered prior to provider reviewing medications as well as gave via wrong route (administered IM in right gluteus)
pt recvd vax & had severe headache & pain; stiffness in neck; called PMD;tx w/ ATB
Lump on leg. Suspected vaccination granuloma. Appeared approx 2 weeks post vaccination. Still present today 2/15/2016. Lump non painful, size of a quarter.
She got her vaccine (pharmacist reporting), she states she experienced headache, neck ache and fatigue.  This happened a few hours after she experienced it.   Pharmacist does not have any other information other than this complaint that she received recently.   She was supposed to get a Pfizer vaccine, but got a flu vaccine instead.
This spontaneous report as received from an unspecified reporter refers to a 38 year old female patient. The patient had allergies to the following drugs; amoxicillin, cephalexin, corticosteroids, loratadine (manufacturer unknown) and potassium clavulanate. On approximately 16-MAR-2016, the patent was vaccinated with PNEUMOVAX 23 (lot # L018503; expiry date: 16-MAR-2017), at a dose of 0.5 ml in her right arm. The day after (on 17-MAR-2016) the patient developed cellulitis and went to the ER (emergency room). The patient was given IV antibiotics at the ER. On an unknown date in approximately 2016 the patient developed swelling. The reporter mentioned that this was the only patient, that she was aware of, that had developed cellulitis. As of 29-MAR-2016, the patient was doing fine and was still taking oral antibiotics. Hence, the outcome of cellulitis was considered recovering, while outcome of swelling was not known. The causality of the events was not reported. The case is linked to 1604USA017274 (same patient link). Additional information has been requested.
Dizziness, Headache, NauseaVomiting, arm sore at injection site,fatigue Narrative:
Information has been received from a 26-year-old male medical student who was vaccinated with VARICELLA vaccine. There was no concomitant medication. Subsequently, he developed 50 chickenpox lesions further described as atypical lesions on his trunk and upper region of his arms. A dermatology department has lookd for a virus in the lesions and can't isolate any. No further details were provided.
Dose number=3; Parsonage-Turner syndrome triggered by Pfizer vaccine; Neuropathy in hands still persists; weakness in left arm; This is a spontaneous report received from contactable patient (Consumer or other non HCP)..A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FF2587) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: VITAMINS NOS; FISH OIL; TURMERIC [CURCUMA LONGA RHIZOME]. Past drug history included: Known allergies:amoxicillin, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2 (Dose number: 1, Lot number unknown, Left arm, brand: Pfizer), administration date: 05Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Lot number unknown, Left arm, brand: Pfizer), administration date: 26Mar2021, when the patient was 66 years old, for COVID-19 Immunization, reaction(s): "Neuropathy in left hand, which later spread to right hand", "Severe sharp pain in bicep, shoulder and radiating into hand.", "Severe sharp pain in bicep, shoulder and radiating into hand.", "Severe sharp pain in bicep, shoulder and radiating into hand.", "pinched nerve in neck". The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: NEURALGIC AMYOTROPHY (disability) with onset 2021, outcome "recovering", described as "Parsonage-Turner syndrome triggered by Pfizer vaccine"; NEUROPATHY PERIPHERAL (disability) with onset 2021, outcome "not recovered", described as "Neuropathy in hands still persists"; MUSCULAR WEAKNESS (disability) with onset 2021, outcome "recovering", described as "weakness in left arm"; IMMUNISATION (non-serious) with onset 05Oct2021, outcome "unknown", described as "Dose number=3". The events "parsonage-turner syndrome triggered by pfizer vaccine", "neuropathy in hands still persists" and "weakness in left arm" were evaluated at the physician office visit. Since the vaccination, has the patient been tested for COVID-19. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (unspecified date) no evidence; polymerase chain reaction: (Sep2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of neuralgic amyotrophy, neuropathy peripheral, muscular weakness. Additional info: Severe sharp pain in bicep, shoulder and radiating into hand.  Neuropathy in left hand, which later spread to right hand.  Pain began about 3 weeks after second dose. Initially diagnosed as pinched nerve in neck.  However, no evidence in MRI.  8 months later diagnosed as Parsonage-Turner syndrome triggered by Pfizer vaccine.  Neuropathy in hands still persists as well as weakness in left arm.
ARM IS RED AND HOT TO TOUCH. NOT PAINFUL . NOTICED TWO DAYS AFTER VACCINE WAS GIVEN
Case number PHEH2015US020167, is an initial spontaneous report received from a healthcare professional (medical assistant) on 07 Oct 2015. This report refers to a 71-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with expired FLUVIRIN (batch number: 1413901 and expiry date: not reported) at a dose of 0.5 ml intramuscularly on 06 Oct 2015. No adverse event was reported following this administration error.
Seen on 1/26/07 and received ProQuad, Prevnar, and Flu vaccine. According to grandmother died on Sunday.  4/17/2007 Received Autopsy Report which reveals COD as sepsis with bronchopneumonia & tracheobronchitis.  Anatomic findings include: small abrasions on central forehead; marked congestion & edema of bilat lungs; enlarged heart; small contusion on right forhead; skin lesions around mouth & nares & dried mucous around nares.
Herpes Zoster diagnosis in a 1 dose varicella vaccine recipient. Painful unilateral rash. Given antiviral treatment.