chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site is itching; Injection site is red; Headache; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site is itching), HEADACHE (Headache), FATIGUE (Felt tired) and INJECTION SITE ERYTHEMA (Injection site is red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported) and Herpes zoster immunization (Patient took Shingles vaccine 3 months before on same area.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HEADACHE (Headache) and FATIGUE (Felt tired). On 07-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site is itching) and INJECTION SITE ERYTHEMA (Injection site is red). On 30-Dec-2020, HEADACHE (Headache) and FATIGUE (Felt tired) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site is itching) and INJECTION SITE ERYTHEMA (Injection site is red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 79-year-old female who experienced nonserious expected events of injection site erythema, injection site pruritus, fatigue and headache.  Event onset occurred Day 1 after the first dose of mRNA-1273, followed by injection site reaction on Day 10. Treatment not reported. Injection site reaction ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 79-year-old female who experienced nonserious expected events of injection site erythema, injection site pruritus, fatigue and headache.  Event onset occurred Day 1 after the first dose of mRNA-1273, followed by injection site reaction on Day 10. Treatment not reported. Injection site reaction ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Right after the Vax patient was weak and spiked a high fever. From that day on she was just not her normal happy self. On 06/15/2015 she had 3 seizures. From that day on she has daily seizures.
Shivering, mild flu-like symptoms, diarrhea with 6 hours, resolved within 12 hours. Swelling and irritation at injection site, still ongoing but improving 72 hours later
Nausea vomiting, dizzy light headed, migraine headache persisting, sweating hold cold started 2 days after..tingling in extremities numbness face arms legs, heart palpatations...could not stand walk..I called 911 my mother was transported to ER.
pt dx w/sz disorder; pt lethargic & running mild temp; 14SEP92 c/o fever & being up all noc, congestion, yellow drainage, diff breathing & eating; pt was twitching; unaware of surroundings; EEG confirmed that pt was having szs; Grand mal sz
Flu symptoms x  3 days followed by chronic cough that will not go away. Sporadic low grade temps with nausea that are brief, about every 2 or 3 days. I've been tested for covid 2x  every week, all tests negative, flu test negative.
Pt experienced worsening condition of her joint pain/arthralgia. Additional information has been requested.
Patient went to take a shower a day after recieving the shot ( about 24hours) and noticed a large red welt on arm, not rash but discoloring "as if someone punched her arm".
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. On or about 13-DEC-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-JUL-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (ST, runny nose, fatigue starting 6/7/22 then tested + 6/9/22) and HYPERSENSITIVITY (sx of allergies) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067421A) for COVID-19 prophylaxis. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.  Previously administered products included for Drug use for unknown indication: Pfizer (Dose Number: 1 Batch/Lot No: EP6955) on 26-Mar-2021 and Pfizer (Dose Number: 2 Batch/Lot No: EP6955) on 16-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2022, the patient experienced COVID-19 (ST, runny nose, fatigue starting 6/7/22 then tested + 6/9/22) and HYPERSENSITIVITY (sx of allergies). At the time of the report, COVID-19 (ST, runny nose, fatigue starting 6/7/22 then tested + 6/9/22) and HYPERSENSITIVITY (sx of allergies) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive through Nasal Swab and positive (Positive) Positive through Nasal Swab. No concomitant medications were reported. No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old patient with  medical history of Pfizer covid-19 vaccine (2 doses) without adverse events who experienced the unexpected event of Covid-19 and other expected event 178 days after  3rd. dose of  mRNA-1273 vaccine. On 09-Jun-2022, SARS-CoV-2 test: positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-years-old patient with  medical history of Pfizer covid-19 vaccine (2 doses) without adverse events who experienced the unexpected event of Covid-19 and other expected event 178 days after  3rd. dose of  mRNA-1273 vaccine.  On 09-Jun-2022, SARS-CoV-2 test: positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a patient's mother concerning her 12 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 03-JAN-2009 was vaccinated with the third dose of GARDASIL. There was no concomitant medication. It was reported that the patient's menstrual cycle was going on 10 days and had hives. At the time of the report the patient had not laboratory diagnostics studies performed. At the time of the report the patient had not recovered. The patient did not seek medical attention. Additional information has been requested.
Soreness in arm shortly after receipt of injection.  Soreness increased throughout the evening.  Next morning injection site inflamed and hot the touch; hard knot at injection site.  Evening of second day fever of 101 degrees.
Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
No adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023.).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 2nd patient out of 6 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719555 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719555:Master case
having a cold; covid symptoms; Warm; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body ache), NASOPHARYNGITIS (having a cold), COVID-19 (covid symptoms) and FEELING HOT (Warm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Herniated disc. Concurrent medical conditions included Blood pressure and Acid dyspepsia.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (body ache). On 24-Mar-2021, the patient experienced NASOPHARYNGITIS (having a cold) and COVID-19 (covid symptoms). On an unknown date, the patient experienced FEELING HOT (Warm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), MYALGIA (body ache), NASOPHARYNGITIS (having a cold), COVID-19 (covid symptoms) and FEELING HOT (Warm) outcome was unknown. Not Provided          No concomitant details were provided. The action taken with the drug was Not applicable.   Reporter did not allow further contact
pt recvd vax 21MAY92 & 48 hrs p/vax c/o low back & knee pain, sore throat & arthralgia; pt denied any rash or fever; no further details were provided;
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Since 31-DEC-2015 the patients were vaccinated with improperly stored GARDASIL (lot # J011272 with expiration date of 21-APR-2016, lot# K014191 with expiration date of 10-MAY-2017, dose, strength and route unknown). The vaccines were stored at 10 Celsius degree for 36 minutes. There was no previous temperature excursion. No adverse effects had been reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-MAR-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2016, the patient was treated at a hospital for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient and mother came in asking for a tetanus vaccine for school. We administered the Tdap Boostrix vaccine. Patient is 7 years old, and Boostrix is only approved for 10 years and older in a pharmacy.  Spoke with mother, and patient has not reported any side effects
requesting 2nd dose, 1 year since 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient came in to pharmacy requesting second dose of Shingrix series, however it had been a year since the first dose was administered. Till the time off reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have lot number or expiration date for first dose. The reporter consented to follow up.
The first thing I noticed is the fever it was really high had body aches and crazy tired. So it went away after the 32 hours.
Patient states she "can't move my arm" shooting pain in arm muscle. Site painful to the touch. Headache.
Patient experienced pain at injection site, chest pain, and back pain as well as muscle tightness and chest congestion starting about 1 week after receiving vaccination. She doesn't feel like its getting any better.
Cellulitis (12 x 17 cm) (L) upper arm Rx. CEPTRIN (500 mg tab) 1 po BID x 10 days.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-JUL-2018, the patient was vaccinated both with PROQUAD (rHA) lot # N019825, expiration date: 09-JAN-2019 (dose, route and site of administration were not reported) and VARIVAX lot# N017395, expiration date: 07-JUN-2019 (dose, route and site of administration were not reported) for prophylaxis. The vaccines were diluted with sterile diluent (MRK INJ). No adverse effects were reported. Product quality complaint was not involved.
Reporter received second COVID-19 vaccine on Wednesday 1/19 with no immediate side effects.  On Friday, 1/22, reporter began experiencing issues blinking.  Saturday morning, 1/23, side effects expanded to her mouth.  She called a 24/7 health hotline and was diagnosed with Bell's Palsy.  She began prednisone  Saturday afternoon (1/23).  Symptoms persist, but do not seem to be progressing.  Has been to her PCP who confirmed initial diagnosis and will schedule appt with endocrinologist to address change in blood sugars with prednisone.  Received the vaccine in her right arm, which is the same side of her face affected.
Headache; Nausea; Pain at the location where the shot was administered; I had period 1 full week early (normally regular), it began the next day after the shot/ might be triggered by the vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 21Apr2021 at 10:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 08:00, the patient's period was1 full week early (normally regular), it began the next day after the shot. The patient was not sure why this happened, but thought it might be triggered by the vaccine. Other than this, patient had headache, nausea and pain at the location where the shot was administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, pain at the location where the shot was administered and period 1 full week early (normally regular), it began the next day after the shot/ might be triggered by the vaccine was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arrhythmia two weeks after first shot.; This is a spontaneous report received from a contactable consumer (patient).   An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0161, expiry date was not provided) via an unspecified route of administration, administered in left arm on 04May2021 at 17:00 (age at vaccination 18-year-old) as 1st dose, single for COVID-19 immunisation in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any medical history or any known allergies. The patient concomitant medications were not reported. The patient was not the diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 17May2021 (two weeks after first shot), patient experienced arrhythmia. The patient visited emergency room/department or urgent care for adverse event. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
I have started having hissing sounds in my right ear after 2 days of the vaccination, it feels scary to keep hearing this sound in my ears & not knowing when it will stop. It?s been a week since vaccination & I am worried if it will ever stop.
I began having lower back pain and then severe, excruciating muscle spasms in my lower back on 4/24/2022 that caused me to be unable to perform normal functions. I took Flexeril for several days, then began a Medrol pak prescription as prescribed by my PCP, which resolved the worst of it.  It was 5 months after my last vaccination, and I have had back pain in the past (though never this severe), so I would expect that it was unrelated to the vaccination.
I had vaccination on 09/22/2022. On 09/25/2022 I started to experience nausea. This was intermittent and happened on 09/26/2022 09/27/2022 and 09/29/2022. I had side stomach pain 09/27/2022. I called my doctor on 09/28/2022.  The doctor suspects its either gallbladder or appendix. I have a CAT Scan scheduled for 09/30/2022.
The employee waited 30 min after the vaccine because she had her Rituxan infusion 10 days prior to the vaccine.  When walking to her car her throat felt itchy, but she blamed it on the cold weather.  During the night she felt excessive thirst and a moderately itchy throat that lasted 2 days post vaccine.
A nurse reported that a child began "screaming at the top of his lungs 4 - 6 hours following receipt of Tetramune. No further information was available at the date of this report. This is 1 of 2 reports from this facility of irritability following receipt of 2 different lots of Tetramune.
12:19am felt an aching near the top right side of my breast plate ( or front where my chest connects to my neck). I felt a nickel size firm but flexible lump that aches and is slightly painful to the touch. The pain radiates down to the injection site that is still swollen and tender.
Swelling at site of injection- Soreness at site L arm and up into L neck.  Temperature elevation up to 102 degrees accompanied by some nausea.
Incorrect dose given to patient - no adverse events occurred - please advise as to when to re-vaccinate.
During School Based Flu event, child was given flu vaccine when parent marked "I do not give consent", but signed the portion where it authorizes consent.  It was not caught by clerical or nursing staff at time of clinic. System was verified prior to administering the dose.
Hours after receiving the vaccine I felt as though I had a headcold with the severity of my symptoms decreasing day-by-day for about eight days. The ninth day, after my "headcold" symptoms had abated; I started finding itchy hives first on my left arm, the left side of my back, and the left side of my upper stomach.  The next day the hives has spread to my scalp, face, ears, left hand, groin, left leg, the upper parts of both my right arm and right leg, the right side of my back, and most of my torso.
fever; headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache). At the time of the report, PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) was resolving.            No Treatment medications were provided. No  Concomitant medications were provided.