chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer also reporter as a private investigator refers to an 11 year old female patient (also reported as 15 year old female). Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, at the age of 11 years old, the patient was vaccinated with GARDASIL (dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were not reported). No concomitant therapies were reported. On an unknown date, 15 minutes after receiving the GARDASIL, the patient experienced grand mal seizure at the unspecified physician's office. On unspecified dates, the patient experienced stomach pain, low blood pressure, syncope with episodes of bradycardia and paralysis. The patient also had missed school on unspecified dates for 18 months as a result of these adverse events. Laboratory diagnostic studies were not reported. The reported stated that the receiving GARDASIL, nearly cost patient's life. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL was not reported. Grand mal seizure, stomach pain, low blood pressure, syncope with episodes of bradycardia and paralysis were considered to be life threatening and disabling by the reporter. Upon internal review, grand mal seizure and paralysis were considered to be medically significant. Additional information is not expected because the reporter refused additional contact.
Information has been received from a physician concerning a 7-year-old male who on 22-Sep-1998 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 31-Jul-2003, the patient developed herpes zoster. The physician indicated that the patient was not hospitalized, but unspecified medical attention was sought. The patient was subsequently treated with acyclovir (Zovirax). In August 2003, the patient was considered to be recovered from the herpes zoster as the lesions were healed. Additional information has been requested.
suspected vaccination failure/received the vaccination for prevention/ shingles; shingles; nerve damage; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure, shingles and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingles vaccine for prevention and a few months later experienced Shingles. The patient also experienced permanent nerve damage. The patient stated that she/he would not wish shingles on his/her worst enemy. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Developed rash at injection site with itching, erythema and warmth as well as inflammation. Rash lasted about a day. Some other generalized hives over the course of the day. Took benadryl, rash resolved on its own after 24 hours
She had COVID vaccine 3rd dose December 4th - No reaction to first vaccine - For 2nd she was feverish and tired for the afternoon only - She got 3rd vaccine on approx 12/4. After 3rd vaccine she had fever, chills for 2 days and pain in the axilla (had vaccine on left arm).  - Two days after vaccination she had about 4 x 2 inch area in the left axilla that was very painful and breasts were very swollen and painful. Her abdomen was also very bloated. She couldn't wear any of her clothes and felt very bad. She was tachycardic and had relateive hypotension for several days. Her urine was also brown for the whole week.  Lump in axilla on the left was painful for 1 week afterward and finally has resolved.  Lymph node is now resolved.  She missed a full week of work due to presumed vaccine reaction.
Nausea, dizziness, fever, sweats.....led to passing out completely in kitchen....fell to floor Ambulance called, vital signs checked, questions asked and answered.  The conclusion was a reaction to one or both of the vaccinations caused the reaction.  Extreme pain at injection site (both given in same area of arm) The pain was tolerable by 10/19/2019
Medication error- Booster dose of Moderna COVID vaccine was due 12/05/2021.  Booster dose was given 11/12/2021
This spontaneous report received from a physician assistant referred to a currently 60 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient who was adalimumab (HUMIRA) was administered ZOSTAVAX (lot: M035694, expiry date not reported) (Product use issue) with sterile diluent. No adverse effects reported.
Arm hurt after shot, woke up and it was very sore, red, swollen, tender,  Now itchy.  Getting better.
sore throat; diarrhea; reaction 6 days later; cough; horrible headache/ different kind of headache; nausea; lump for 3 days; soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (horrible headache/ different kind of headache), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later) and COUGH (cough) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (for 6 weeks) in March 2020. Concomitant products included LEVOTHYROXINE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CLONAZEPAM (KLONOPIN), OMEPRAZOLE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MASS (lump for 3 days) and PAIN (soreness). On 10-Mar-2021, the patient experienced HEADACHE (horrible headache/ different kind of headache), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later), COUGH (cough) and NAUSEA (nausea). On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, HEADACHE (horrible headache/ different kind of headache), DIARRHOEA (diarrhea), ADVERSE REACTION (reaction 6 days later), COUGH (cough) and NAUSEA (nausea) outcome was unknown and OROPHARYNGEAL PAIN (sore throat), MASS (lump for 3 days) and PAIN (soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was not reported.
Small cyst on kidney; Stomach pain; Will not be getting the second vaccine; Vomiting; Arm is still sore on occasion at the shot site; Same as first event but worse; Diarrhea; Flashes of adrenaline or anxiety; Chills; Nausea/ Nausea became worse; Arm bruised for 1 month; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), CONDITION AGGRAVATED (Same as first event but worse), RENAL CYST (Small cyst on kidney), DIARRHOEA (Diarrhea) and ANXIETY (Flashes of adrenaline or anxiety) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Nausea, Diarrhea and Chills.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced NAUSEA (Nausea/ Nausea became worse). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ANXIETY (Flashes of adrenaline or anxiety) and CHILLS (Chills). On 24-Mar-2021, the patient experienced CONDITION AGGRAVATED (Same as first event but worse). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), RENAL CYST (Small cyst on kidney), CONTUSION (Arm bruised for 1 month), INTENTIONAL DOSE OMISSION (Will not be getting the second vaccine), VOMITING (Vomiting) and VACCINATION SITE PAIN (Arm is still sore on occasion at the shot site). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea/ Nausea became worse) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Dramamine.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional1
No adverse effects reported; the patient inadvertently received an expired dose of PNEUMOVAX 23; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.   On 07-MAY-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # N030111, expiration date 21-APR-2019, for prophylaxis. No adverse effects were reported.
MY NECK HAD A LARGE LYMPHNODE ABOUT THE SIZE OF A HALF DOLLAR ON THE LEFT SIDE & SO I WENT TO DR & WAS TOLD TO WATCH IT & TAKE ANTIBIOTICS
Received the shot, still got shingles/suspected vaccination failure; still got shingles; Pain was excruciating, months with pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-Jan-2023. Reporter's Comment: This case was received from patient via interactive digital media. The reporter stated that even though received the Shingles shot and still got shingles and the pain was excruciating. The reporter stated it was getting better but now going on two months with pain now. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-FEB-2010, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
SOME WEIRD ABNORMAL SIDE EFFECTS FROM COVID SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced some weird abnormal side effects from covid shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from some weird abnormal side effects from covid shot. This report was non-serious.
received her first Pfizer vaccine on 10Feb2021.  She has tested positive today; received her first Pfizer vaccine on 10Feb2021. She has tested positive today; This is an initial spontaneous report from a contactable pharmacist. A 66-years-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced drug ineffective, covid-19 on 23Feb2021. Clinical course reported as Pharmacist calling from (Pharmacy name) asking for guidance on a patient, female, aged 66 who received her first Pfizer vaccine on 10Feb2021. She has tested positive today, she wants to know if she can still receive her second dose on 10Mar2021? Caller refused transfer. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  No follow-up attempts are possible. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Severe paresthesia and heaviness in lower limbs; This is a literature report. A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fever" (unspecified if ongoing); "fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), 6 days after the suspect product(s) administration, outcome "unknown", described as "Severe paresthesia and heaviness in lower limbs". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Unknown results; Electromyogram: Normal; Heart rate: Unknown results; anti AchR: Unknown results; Unknown results; Unknown results; Unknown results; Magnetic resonance imaging neck: Normal; Neurological examination: Normal; Respiratory rate: Unknown results; Tilt table test: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200764439 Same article/patient and different drug/event.
NECK PAIN; LOWER BACK PAIN; ARM PAIN WHERE VACCINE WAS RECEIVED; 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: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced neck pain. On MAR-2021, the subject experienced lower back pain. On MAR-2021, the subject experienced arm pain where vaccine was received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck pain, lower back pain and arm pain where vaccine was received was not reported. This report was non-serious.
patient was due for Pediarix but got Kinrix instead; a patient who is 5 months old inadvertently received a dose of Kinrix; a patient who is 5 months old inadvertently received a dose of Kinrix/Kinrix was the patient's 2nd DTaP and 2nd Polio; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 01-NOV-2023, the patient received Kinrix. On 01-NOV-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient was due for Pediarix but got Kinrix instead), inappropriate age at vaccine administration (Verbatim: a patient who is 5 months old inadvertently received a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: a patient who is 5 months old inadvertently received a dose of Kinrix/Kinrix was the patient's 2nd DTaP and 2nd Polio). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 10-NOV-2023 The nurse reported that a patient who was 5 months old inadvertently received a dose of Kinrix, which led to inappropriate age at vaccine administration. The patient was due for Pediarix but got Kinrix instead, which led to wrong vaccine administered.  The Kinrix was the patient's 2nd DTaP and 2nd Polio dose, which led to inappropriate schedule of vaccine administered. The reporter stated, had they received Pediarix, it would have been the patients 3rd dose of Hepatitis B. The reporter consented to follow up via email.
I had a large very  painful swellings in the left arm just above and below the elbow on the inside. I pushed on them and they gave way. No longer swollen but still quite painful.    Lymph node? muscle? not at the at the site but farther down the same arm.
Seen at Emergency Room for swelling of tongue, palpitations and pruritis. Diagnosed as allergic reaction.
Myalgia, arthralgia x 3 days. Malaise, temperature to 100.5, headache, arm redness, hot, swelling. TX rest, ice, Advil, Fluids.
That evening after the vaccine, I notice a pimple-like red bump on my left side of the forehead. The next day, I noticed it started to spread the next 2 days on my face and worked its way to my hairline and down the left side of forehead to my left eye and left cheek. On day 3, I decided to go to the ER. They ran some tests, did an eye exam and gave me a medication named Valtrex and diagnosed me with Shingles. 2 days later, I was still having problems with my left eye and it was completely swollen shut. I went to another ER. They ran some more tests and I was prescribed an ointment for my eye and a pain medication Hydrocodone. Within a few days, my eye was back to normal and my shingles was also resolved.
I noticed Heart skipping beats and chest discomfort 8 days after the Vaccine.  It has remained an issue for 7+ weeks now and continues to skip many times each hour.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Patient felt dizzy, no other sx. BP was 142/75 P79 O2sat96.  Had her sit for 10 more minutes and gave her apple juice.  She felt better afterwards and felt safe to leave with her daughter.
Received MMR vaccine within about 15 minute started itching, difficulty swallowing, and rash. Had taken Benadryl and Pepcid about 15-30 minutes prior to receiving the vaccine. Then given Tagamet 400mg and 125mg of solu-medrol.  These symptoms improved after treatment and then around 1:40pm numbness, tingling, burning, and tremors started.  The numbness, tingling, and burning was from knees down.
pt exp pain @ inj site;arm sore (upper) x 3 days increasingly worse-pt in tears;
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 32-year-old nursing mother who experienced headache, runny nose, body aches and feeling tired. At 32 years of age, the patient received a dose on 17-Dec-2003. Medical History: The patient had no relevant medical history. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 17-Dec-2003. Dose regimen was 0.5 mL (intranasal). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 18-Dec-2003, the patient, a nursing mother, experienced headache, runny nose, body aches and was "feeling tired". As of 19-Dec-2003, all events were unresolved. The subject stated "I wasn't supposed to have Flumist because I'm breastfeeding." Related Case: See related caseHQWYE871922DEC03 (baby case). No additional information was available at the time of this report.
This spontaneous report as received from a physician refers to a patient of unknown gender, over the age of 12. No medical history, concurrent condition and concomitant medications were reported. On 09-JUL-2018 the patient was vaccinated with PROQUAD (lot#R004441, expiry date AUG-2019) for prophylaxis (drug administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (Merck sterile diluent). No adverse effect was reported. No product quality complaint was present.