chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NEUROPATHY LEGS; MORE JOINT PAIN WHEN CLOSE TO INJECTION TIME; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (NEUROPATHY LEGS) in a 47-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis and Rheumatoid arthritis.    Concurrent medical conditions included Panuveitis and Rheumatoid arthritis.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, cf. On 21-Aug-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (NEUROPATHY LEGS) (seriousness criterion medically significant) and ARTHRALGIA (MORE JOINT PAIN WHEN CLOSE TO INJECTION TIME). At the time of the report, NEUROPATHY PERIPHERAL (NEUROPATHY LEGS), HERPES ZOSTER (Shingles) and ARTHRALGIA (MORE JOINT PAIN WHEN CLOSE TO INJECTION TIME) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication were not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 47-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Neuropathy peripheral together with non-serious event of Herpes zoster. The event occurred on unknown date after receiving the first dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Herpes zoster occurrence 2 days after receiving the first dose of mRNA-1273 could be contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 47-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Neuropathy peripheral together with non-serious event of Herpes zoster. The event occurred on unknown date after receiving the first dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Herpes zoster occurrence 2 days after receiving the first dose of mRNA-1273 could be contributory factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
fever; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in Mar2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he just had his second shot last night. He had a fever since yesterday (Mar2021). The outcome of fever was not recovered.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ringing in Ears; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Ringing in Ears) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Graves' disease on 05-Oct-2020, Hemochromatosis in 2021 and Phlebotomy (Phlebotomy3 times, HEPA vaccine 1st dose). Previously administered products included for Product used for unknown indication: Hepatitis A (dose 1). Past adverse reactions to the above products included No adverse event with Hepatitis A. Concurrent medical conditions included Drug allergy (Dilaudid), Cirrhosis liver since 2021, Allergy to antibiotic (E-Mycin), Allergy to antibiotic (Ciprofloxin) and Allergy to antibiotic (Rocephin). Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) and THYROID (ARMOUR THYROID) from 2021 to an unknown date for Graves' disease, ZOLPIDEM TARTRATE (AMBIEN) from 2000 to an unknown date for Insomnia, ASCORBIC ACID, COLLAGEN BOVINE, HYALURONATE SODIUM (VITAL PROTEINS ORIGINAL COLLAGEN PEPTIDES WITH HYALURONIC ACID + VITAMIN C) from 2021 to an unknown date for Supplementation therapy, COLECALCIFEROL (VIT D3) from 2010 to an unknown date for Vitamin D deficiency.    On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021 at 6:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in Ears). At the time of the report, TINNITUS (Ringing in Ears) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered TINNITUS (Ringing in Ears) to be possibly related.    Treatment information not provided by reporter.   This case was linked to MOD-2021-382243, MOD-2021-396175 (Patient Link).
was sick; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media. This case involves an elderly patient who was sick (illness), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) patient reported that he/ she did not have a flu shot since the mid-70s when he/she was sick as hell (illness). It was also reported that to his/her knowledge, no one had gotten the flu from the patient or patient's family. The patient must be immune to the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on batch number for this case.
Itchy red; Rash like on arm; Lump in armpit; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 55-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248; Expiration Date: Apr2021), intramuscular, administered in Arm Right (Upper Right Arm) on 25Jan2021 (age at the time of vaccination was 55 years) at 16:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to ae(s) and prior vaccinations was within 4 weeks were reported as none. On 27Jan2021, the patient experienced lump in armpit. On 06Feb2021, the patient experienced itchy red and rash like on arm. Therapeutic measures were taken as a result of itchy red and rash like on arm which included topical hydrocortisone cream. The outcome of all the events was recovered on an unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.
dose 1 12/22/2020 pfizer EL0140 lot  Pt has covid 19 8/12/2021
After the second dose arm was sore for about 2months. In July 5th 2019 started losing eye sight. Doctors started running test such as MRI and CT scan. In 2020 was Diagnosed with MS.
Ear throbbing and pressure, 24 hours on and off Fever(101-102.8), 48 hours on and off
I went to Hospital via ambulance because I was having heart palpitations and chest pains. It started the night before and went into the next day. I am seeing a cardiologist 9/10/2021 for follow up. Cardiologist.
I felt dizzy, hot, dry cotton mouth. I saw little stars but then it got better.
Case number PHEH2014US010040 is an initial spontaneous report from a nurse received on 12 May 2014. This report refers to a patient of an unknown gender. The patient intramuscularly received only powder component of MENVEO (batch number: unknown) mixed with bacteriostatic saline instead of Men CYW-135 liquid component. No adverse event reported following this medication error.
chest tingling, hoarseness, feeling flushed treated with 25 mg. oral Benadryl with quick resolution of symptoms
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 24-FEB-2017) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 416, 80 1172, 336, 168 and 24 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 49 (9.444444444 Celsius degrees), 47 (8.333333333 Celsius degrees), 59 (15 Celsius degrees) and 48 (8.888888889 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Arm sore, elevated heart rate, body aches day of 2nd moderna dose. Day after chest tightness and pain when breathing deeply, coughing. Went to the doctor on 11-2, they did a Covid test, said lungs and heart sounded fine. Covid test negative - prescribed z-pack antibiotics and told if it didn?t get better would look into heart issues.
SEVERE HEADACHES, FAINTING, NAUSEA, IRREGULAR HEART BEATS, BLURRED VISION, BONES ACHING, TACHYCARDIA, SHORTNESS OF BREATH, RASHES, CHEST PAIN, IRRITABILITY, MOOD SWINGS, HOSPITALIZED NUMEROUS TIMES.
A week after 1st dose, patient complains of itchiness at site of injection.  3 days later  - no more side effects.
Possible deviation from the recommended interval between the first and second moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possible deviation from the recommended interval between the first and second moderna covid-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-106080 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 60-year-old female patient who received SHINGRIX. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th April 2018, 1 days after receiving SHINGRIX, the patient experienced feeling cold, pain in arm, erythema of extremities, fever and chills. On 7th April 2018, the patient experienced headache. On 14th April 2018, the patient experienced vomiting. On 14th April 2018, the outcome of the feeling cold, pain in arm, vomiting, erythema of extremities, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the feeling cold, pain in arm, vomiting, erythema of extremities, headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. On 7th April 2018, 3 days after receiving SHINGRIX, the patient experienced headache. On 14th April 2018, 10 days after receiving SHINGRIX, the patient experienced vomiting. The patient planned to follow-up with her physician on an unknown date.
Patient received double dose of vaccine. Monitored for adverse reactions. None noted. Will continue to monitor.
Headache, Myalgia, NauseaVomiting, Syncope, injection site soreness, chills Narrative:  Other Relevant History:
Patient broke out with 2 spots that acted and looked like shingles according to the patient. She applied a soy shingle relief product that she bought at the fair and the spots went away.
Headache, Myalgia, Fever, Lethargic, Sore Around Injection Site Narrative:
Stroke, thromboembolic source.  Suspected due to autoimmune coagulopathy . Symptom  onset was ~3 weeks after last vaccine. Anticoagulation initiated with enoxaparin and warfarin for destination therapy of warfarin x 3 months.
Pt had LOC for a few seconds p/inject; stood up, fell & hit head on floor; paramedics called, initial BP 140/100, dec to 120/70 p/a few minutes; refused transport to ER; pt doing fine per mom on 28FEB92 advised to notify MD;
High fever (102/103), chills, severe muscle aches, splitting migraine headache.  A week later I had my period and experienced heavy bleeding and passing large blood clots not normal to my usual period.  Still having headaches and its been 3 weeks.
Patient described body aches and flu like symptoms and developed atrial fibrillation at 36 hours post injection.
Patient had rash at the injection site and on all around torso. Patient felt sick for 2 weeks. Patient now has sinus infection.
Client verbalize tingling of the tongue and tip of fingers.  Client evaluated by onsite paramedic.  Client symptoms was not resolved and client was advised to seek additional evaluation but refused.  Client was released at 2:10 pm accompanied by spouse.
some people report trouble across their back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (some people report trouble across their back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (some people report trouble across their back). At the time of the report, MUSCULOSKELETAL DISCOMFORT (some people report trouble across their back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Reporter stated that the nurse told her daughter that some people experienced same trouble across their back(muscle pain) after getting the vaccine. Reporter was unable to provide more information regarding these patients.   This case was linked to MOD-2021-377083 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up information received contains non significant information. Reporter statement was added.
Patient indicated that she usually faints for about 10 seconds or less after any type of vaccination. Patient attested that it is normal for her and that "it runs in the family". Patient was nervous and held onto a family before right before injection. Patient's eyes began to close and she fainted as the vaccine was being injected. Her eyes were closed for about 5 seconds, and they reopened. Patient was responsive, she nodded her head when I asked if she was doing better. After about 10 seconds, patient asked if she could lay on the floor. The family member and I moved her slowly to the floor where she rested for another 5-7 minutes. During the time she was on the floor, I continued to ask how she was feeling and she communicated she was better, and that she will be fine. After about 6 minutes of resting, patient got up, and said "I'm fine." Patient was at the pharmacy for about 10 minutes. She confirmed she was fine and asked to leave.
patients received a vaccine that under went a temperature excursion; No adverse event; patients received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patients received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients received a vaccine that under went a temperature excursion).    Patients weight was reported as 18.7. Vaccine administration site was reported as LQ. Concomitant medication list was not provided. It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that under went one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion.The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion.Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08-Aug-2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18-Aug-2022. Number of vials/ per doses impacted was 1 vial. The excursion occurred on 07-Aug-2022. The vials were not punctured until they were used for a patient and then discarded. No side effects were reported. Treatment information was not provided.
My son was given these same vaccinations on October 20, 2017. I did not notice swelling and discoloration in the first doses but with the second series, the adverse reactions are very noticeable. There is swelling at the site of each intramuscular injection in both thighs. Two vaccinations were administered to his left thigh and the swelling there is larger. It feels like there is a mass under my baby's skin. On the left thigh there is also a dark spot that was not there prior to this second dose of vaccines. I believe the PEDIARIX combination was injected into my son's right thigh where there is some swelling under the skin and a small bump on the top layer of skin. The doctor stated that this is a common reaction. She advised me to massage the affected areas and to apply cold compresses to the affected sites.
s/p primary rabies prophylaxis APR97 w/TVA p/the booster (for post exp proph) initially had only pain @ the site (lt deltoid) but 6hr later devel total body ache (arthralgia & myalgia)
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with ZOSTAVAX. No concomitant medications were provided. Immediately afterwards the patient experienced a panic attack and elevated heart rate. The pharmacist had the patient sit still for a while (time unspecified) and the patient fully recovered. The outcome of panic attack and elevated heart rate was reported as recovered. The patient did not seek medical attention. Additional information has been requested.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified date in 2016 (reported as "within the last 2 weeks"), the patient was vaccinated with ZOSTAVAX (lot # M010486, expiry date 25-MAY-2017), 1 injection, subcutaneously. At the same time the patient received PREVNAR. It was reported that the patient had excessive swelling and pain for ZOSTAVAX in injection site for longer than physician advised. The patient was advised to take TYLENOL and use warm compress. At the time of the reporting the outcome of excessive swelling and pain for ZOSTAVAX in injection site was unknown. This is one of two reports received from the same source. (Linked report MARRS # 1608USA006547). The linked report refers to a patient who received ZOSTAVAX with the same lot number reported and experienced same events. Additional information has been requested.
A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving Nasal FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. Patients were administered FLUMIST that underwent multiple temperature excursion. The outcome of the event of PATIENTS ADMINISTERED IMPROPERLY STORED FLUMIST was unknown. The report was considered to be non-serious.
Left leg swollen, hot, red and tender to touch. Left thigh measured 34cm compared to right leg at 30cm.