chrisvoncsefalvay/vaers-outcomes huggingface dataset:
scar tissue; it felt like she was being stabbed; Most painful vaccine she ever got; was in pain for a few weeks in the arm/getting more and more painful; got a "frozen shoulder"/Could not move arm much; Still is not completely healed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Froze arm" (unspecified if ongoing), notes: She has had a "Froze arm" before. The patient's 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: SCAR (medically significant), outcome "recovered with sequelae", described as "scar tissue"; STAB WOUND (non-serious), outcome "recovered with sequelae", described as "it felt like she was being stabbed"; PAIN (non-serious), outcome "recovered with sequelae", described as "Most painful vaccine she ever got"; PAIN IN EXTREMITY (non-serious), outcome "recovered with sequelae", described as "was in pain for a few weeks in the arm/getting more and more painful"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "recovered with sequelae", described as "got a "frozen shoulder"/Could not move arm much"; IMPAIRED HEALING (non-serious), outcome "recovered with sequelae", described as "Still is not completely healed". The events "scar tissue", "it felt like she was being stabbed", "most painful vaccine she ever got", "was in pain for a few weeks in the arm/getting more and more painful", "got a "frozen shoulder"/could not move arm much" and "still is not completely healed" required physician office visit. Therapeutic measures were taken as a result of scar, stab wound, pain, pain in extremity, joint range of motion decreased, impaired healing.  Additional information: the pharmacist gave her the vaccine and as she gave it felt like was being stabbed. Most Painful vaccine she ever got. She was in pain for a few weeks in the arm and then she got a "frozen shoulder". From November - January it was getting more and more painful. Could not move arm much. She has had a "Froze arm" before. Went to PCP in February. Had A "Manipulation" where they put you to sleep and break the scar tissue. Went to physical therapy in early June. Resolved in Sep2022-Oct2022. Still is not completely healed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I began to feel nauseous about 11.5 hours after my shot. I got chills, total body aches, nausea (though I never vomited), and headache for 15 solid hours. Afterward I felt weak, like getting over the flu. This is follow-up to VAERS .
Initial case received from the patient on 06 May 2014. A 62-year-old female patient had received an intramuscular dose of FLUZONE on 04 December 2013 (batch number UH893AB). The patient had a medical history of psoriasis, food allergies, and penicillin allergy. No illness was reported at time of vaccination. The patient did not receive any previous dose of flu vaccine. It was not reported whether concomitant medications were taken. On 04 December 2013, a few hours after the vaccination, the patient experienced tingling in the back of the throat, then to the tongue and lips. The lips were swollen. The patient went to the ER and had to keep clearing the throat. The patient received corrective treatment with PEPCID and IV BENADRYL in the ER and was released (no admission to the hospital). Symptoms were still present in the morning with swollen lips. No complementary investigations were reported. The patient's outcome is recovered. Additional information was received from the reporter on 06 May 2014, which noted that the patient had also experienced throat constriction. No other significant information was reported. Follow-up information was received on 04 June 2014 from a consumer who is also the patient. The 62 year-old adult female had a history of multiple allergies. The patient had an additional event of throat swelling. She was seen in the emergency room and treated with BENADRYL and PEPCID. According to the reporter, she was monitored in the ER for a few hours and then discharged to home. She reported that the next morning she continued to have some swelling and tingling of lips and throat, but it was decreased. The symptoms subsided and she had no other symptoms. Outcome was recovered. Follow-up information was received from the reporter on 23 June 2014, which confirmed the contact information for the emergency department where the patient was treated. No additional information was reported. Documents held by sender: none.
Dry skin at injection arm; Itchiness at rash; Rash all over muscle of injection arm; Chills; Aches and pains; Aches and pains; High fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchiness at rash), DRY SKIN (Dry skin at injection arm), PAIN (Aches and pains), MYALGIA (Aches and pains) and PYREXIA (High fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Blood pressure high and Cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN (Aches and pains), MYALGIA (Aches and pains), PYREXIA (High fever) and CHILLS (Chills). On 10-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash all over muscle of injection arm). On 11-Mar-2021, the patient experienced RASH PRURITIC (Itchiness at rash). On an unknown date, the patient experienced DRY SKIN (Dry skin at injection arm). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at a dose of 500 mg every six hours. On 09-Mar-2021, PAIN (Aches and pains), MYALGIA (Aches and pains), PYREXIA (High fever) and CHILLS (Chills) had resolved. At the time of the report, RASH PRURITIC (Itchiness at rash) and VACCINATION SITE RASH (Rash all over muscle of injection arm) had resolved and DRY SKIN (Dry skin at injection arm) had not resolved.            Concomitant medications reported were blood pressure medicine, diabetes medicine and cholesterol medicine.   This case was linked to MOD-2021-052974 (Patient Link).
I contacted COVID-19; I contacted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Oct2021 (Lot number: ff8859) at the age of 24 years as dose 3 (booster), single, administration date 09Feb2021 (Lot number: EL3247) as dose 2, single and administration date 19Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not administer any other vaccine during last 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 17Jan2022, outcome "recovering" and all described as "I contacted COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. No follow-up attempts are possible. No further information is expected.
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 04-Apr-2014. The healthcare professional reported that they inadvertently administered expired FLUMIST to a patient 24-March-2014 which started on 04-Apr-2014. The outcome of the event of we inadvertently administered expired FLUMIST to a patient is unknown. The report was considered to be non-serious.
Increased fever, not relieved with tylenol or motrin. Excessive swelling with discoloration in right leg and arms. Private MD notified and several days later client referred to ER.
CHILLS;  FEVER 100.6; STARTED AS A BAD NECK HEAD AND EYE PAIN AND CONTINUED WITH A BODY ACHE; JOINT PAINS; AND FATIGUE.  AFTER SEVEN HOURS OF HAVING IT, I TOOK 2  500 TYLENOL AND GOT INTO A LUCK-WARM BATH.  I WAS FINE HALF HOUR AFTER.
blotchy; bit lumpy under the skin; itching; started having itching at the vaccine site on left arm; started having itching at the vaccine site on left arm, it was red, and the size of a coin.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic lyme disease, chronic fatigue syndrome (CFS), hypothyroid, methylenetetrahydrofolate reductase (MTHFR) mutations and others. The patient's known allergies included sensitive to sulphur. Concomitant medication included rubidium, selenium, catalase, herbal nos, superoxide dismutase and animal unspecified as a thyroid supplement from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 08:00, day seven after receiving vaccine, the patient experienced itching at the vaccine site on the left arm, it was red, and the size of a coin. Throughout the day, the lesion started growing and the itchiness travelled away from the vaccine site. On 28Mar2021, the patient experienced red, itchy, blotchy and a bit lumpy lesion under the skin and the area had grown to about eight inches by five inches. As the days went by, patient only experienced mild itching about two times a day. It was reported that the patient would like to know what caused this, and if there was a concern for the second vaccine which was scheduled for 10Apr2021.  The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events itching, red, itchy, blotchy and a bit lumpy lesion under the skin was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Developed rash on bilateral wrists, inguinal folds, and along bra line.  Non-raised, non-pustule. Resolved shortly thereafter with Benadryl.
This spontaneous report as received from a medical assistance refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L42266, expiration date was not reported) (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Stroke- Vomiting, headache in back of head, tingling in arms and face after the second vomit. Vomited 3 times total. This started on 2/12 and I made it home and laid in bed thinking I had a stomach bug. Went to primary care doc on 2/15 and he said to go to the ER.
Itching red rash that is painful and warm to touch. Benadryl cream placed for itching, followed by hydrocortisone cream and advil.
I had a sore arm for about a day after receiving the vaccine. In 12/2022, I began to have tremors in both hands. The morning time is the worst and by the end of day it calms down. The symptoms got worse, and I recently went to the doctor. I have started taking medication which is helping. At this time, we are waiting on how the medication works.
Pt unable to lift right arm. Pt sent to MD for EMG/nerve conduction study and was dx'd with neuropathy to brachial raidalis nerve in right arm.
red, itchy rash all over body from her neck down to her feet; red, itchy rash all over body from her neck down to her feet; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC and RASH ERYTHEMATOUS in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced RASH PRURITIC and RASH ERYTHEMATOUS. The patient was treated with CLARITIN at an unspecified dose and frequency. On 02-Apr-2021, RASH PRURITIC and RASH ERYTHEMATOUS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Symptoms include body aches, nasal congestion, postnasal drainage, dry cough and headache, while symptoms do not include fever. Onset was gradual 2 day(s) ago. The symptoms occur constantly. The patient describes this as moderate in severity and worsening. Symptoms are exacerbated by activity. Symptoms are relieved by lying down. Associated symptoms include shortness of breath, fatigue and diarrhea, while associated symptoms do not include nausea or vomiting.  Note: pt symptoms started on Tuesday with joint pain/headache wednesday pt states chest was hurting with a cough. today pt states she woke up with "a bear hugging my lungs" pain 9/10
Patient came to the pharmacy today to report a possible adverse reaction to the PNEUMOVAX 23. Because she had received flu vaccines without complications in previous years, she is more likely to rule out the reaction as being a result of the FLUZONE. Similarly, this is the first time receiving the PNEUMOVAX 23, so she is more inclined to believe that the reaction is a result of the PNEUMOVAX 23. She reported redness, a warm sensation and pain in the area of vaccination. She self-treated with OTC Ibuprofen and an ice pack and a fan. Her symptoms have subsided by Monday night and/or Tuesday morning.
4 hours post vacc - headache, 24 hours post vacc - headache, fever, swelling, rash, severe itching.  48 hours post vacc - headache, swelling in elbow, forearm, itching.  72 hours post vacc. - swelling in elbow, forearm, itching.
Urinary incontinence; Joint pain; Muscle Pain; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), MYALGIA (Muscle Pain), CHILLS (Severe chills) and URINARY INCONTINENCE (Urinary incontinence) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) and LEVOTHYROXINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 10-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), MYALGIA (Muscle Pain) and CHILLS (Severe chills). On 11-Mar-2021, the patient experienced URINARY INCONTINENCE (Urinary incontinence). At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle Pain), CHILLS (Severe chills) and URINARY INCONTINENCE (Urinary incontinence) outcome was unknown.            She did not receive treatment for her symptoms.
This 4th dose was pulled from a primary series bottle rather than from a bivalent booster bottle.
I have been extremely dizzy since the day after. So dizzy sometimes I still throw up. It has been a month and I am still dizzy
Got my second shot Tuesday around 12:15. Everything was fine, no symptoms until Wednesday night. I went to bed around 11. I had diarrhea all night, at least six times. Headache, fatigue, and I stayed in bed until Friday morning.
Itchy red Rash formed on chest, spread to belly, all over back and lower buttocks now. Doctor prescribed hydroxyz, and triamcinolone acetonide
Pt experienced headache and dizziness immediately after injection. Approximately 30 mins later the patient began experiencing chest tightness. The patient received 50mg Benadryl and was transferred to the emergency department within about 20 mins.
Very heavy clotting during my menstrual cycle.  Blood clots larger than the size of a quarter.  Accompanied by Heavy cramping
Vertigo daily since vaccine / I get vertigo when I lay down, bend over, and stand up. I have to hold onto something to keep from falling.; dizziness; I cannot keep my balance; I have to hold onto something to keep from falling.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 13:15 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. Past drug history included: Adhesive tape, reaction(s): "Allergy". The following information was reported: VERTIGO (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Vertigo daily since vaccine / I get vertigo when I lay down, bend over, and stand up. I have to hold onto something to keep from falling."; DIZZINESS (non-serious) with onset 07Dec2021, outcome "not recovered", described as "dizziness"; BALANCE DISORDER (non-serious) with onset 07Dec2021, outcome "not recovered", described as "I cannot keep my balance"; FEAR OF FALLING (non-serious) with onset 07Dec2021, outcome "not recovered", described as "I have to hold onto something to keep from falling.". It was unknown if therapeutic measures were taken as a result of vertigo, dizziness, balance disorder, fear of falling.  The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
I started with having to clear my throat. Then I had sneezing and sniffles with a runny nose. On the third day I developed a cough. On the 4th day my upper torso felt like a punching bag, and that lasted for 2 days. It took about 7 or 8 days to start feeling better. I was tired and had trouble sleeping through the night. I took NYQUIL towards the end to help with sleeping. I also contacted my doctor and I was prescribed Z-PAK and prednisone. I also had a stuffy nose.
About 1 1/2 hrs p/receiving vax fell asleep woke c/o stomach ache had a BM went back to sleep woke & vomited has fever of 100+ mom states it is going up; contacted MD felt it was a bit soon however mom has an appt w/MD;
episodes of headache, weakness and fatigue the entire week after vaccine.  This lasted all day on 10/3/21, no symptoms on 10/4.  The rest of the week symptoms lasted 4 to 5 hours different time of the day up until 10/8/21.
ITCHING; REDNESS; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, blood pressure, and rheumatoid arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered in left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 PCR test positive (NR: not provided) Positive. On 12-MAR-2021, the patient experienced itching. On 12-MAR-2021, the patient experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching, and had not recovered from redness. This report was non-serious.
Child developed lump on leg at injection site.  Six weeks later the site turned purple, then black. Area is about 5 mm, slightly raised and hard to touch.
Ipol administered erroneously in lieu of Tubersol, medical assistant administered 0.1ml subdermally, but then realized that she grabbed MDV of Ipol rather than Tubersol with no reported adverse event; small amount of Ipol (0.1ml) was administered subdermally with no reported adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 23 years old female patient who was administered vaccine IPV (vero) [IPOL] erroneously in lieu of tuberculin test [Tubersol], medical assistant administered 0.1ml subdermally, but then realized that she grabbed mdv of ipol rather than tubersol with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Aug-2023, the patient received 0.1ml dose of suspect IPV (vero), suspension for injection (batch number: W1A191M; expiry date: 16-Feb-2025) via subdermal route in the forearm nos for TB skin test erroneously in lieu of tubersol (Tuberculin Test), solution for injection (with an unknown strength, batch number, expiry date), medical assistant administered 0.1ml subdermally, but then realized that she grabbed mdv of ipol rather than tubersol with no reported adverse event (wrong product administered) (incorrect route of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 the 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.
diarrhea >7 weeks, long, thin, chunks; 4-6 times a day, moderate quantity, no fever, weight change, lightheadedness, chills, nausea, vomiting, bloating; mild intermittent suprapubic abdominal pain lasting 5-10 minutes