chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible itches all over neck; neck looks like a turkey neck; could not sleep; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 05Mar2021 (at the age of 84-years-old) as dose 1, single for COVID-19 immunisation at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced had "terrible itches" all over neck, on the outside of neck, not inside on 05Mar2021. It was reported that it started that Friday evening, very light, and continued and worsened each day until today when the patient finally took medication for it. It was also reported that her neck looks like a turkey neck and could not sleep due to the terrible itching on an unspecified date in Mar2021. The patient called her doctor on 08Mar2021 (reported as yesterday) and was advised to take fexofenadine hydrochloride (ALLEGRA).  The patient took Allegra on 09Mar2021 as a result of the events "terrible itches" all over neck and neck looks like a turkey neck.  Her neck was feeling better on 09Mar2021 (reported as today). The outcome of the event "terrible itches" all over neck and neck looks like a turkey neck was recovering and outcome of event could not sleep was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Spontaneous menstrual bleed ~31 hours after vaccination. Only lasted for about 1 hour.
Information has been received from a healthcare professional, author of the published article, referring to one vaccinated student, with a pre-existing immunocompromising condition, who was admitted to the hospital for observation for suspected varicella because of fever and a maculopapular rash with 14 lesions, involving the back, torso and buttocks. A lesion specimen from the one hospitalized case-patient was tested at the hospital laboratory by polymerase chain reaction (PCR). Information regarding laboratory results were not specified. Additional information has been requested. This is one of several reports received from the same source.
After vaccination mother & MA reported that child had breath while crying and went limp/closed yes and became pale. Aroused immediately, cried more but remained pale. Re-examined w/ clear lung sounds & normal heart.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided          No relevant concomitant medications reported. After second dose HCP told her to take Ibuprofen if she needs it. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
1 day subsequent to receiving one dose of varicella virus vaccine live the pt experienced a 3 cm erythema at injection site. The pt developed 5-6 vesicles at the injection site.
No other adverse effects were reported.; a patient received a dose of PROQUAD following a temperature excursion.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug allergies/reactions and concomitant medications were not provided.  On 10-DEC-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# S006830, expiration date 02-SEP-2020, strength, dose and route were not provided) for prophylaxis following a temperature excursion with Merck sterile diluent 5 ml (lot # and expiration date were unknown).  The improperly stored of vaccine experienced a temperature of 6 degrees Fahrenheit (F) to 14 F (-14 degree Celsius to -10 degree Celsius) (-9.9 degree Celsius) for 2 hours. The previous temperature excursion included 15 F to 46 F (-9 degree Celsius to 8 degree Celsius) (-1.9 degree Celsius) for 2 hours 30 minutes. The digital data logger was involved. No other adverse effects were reported.
Patient reported possible fever following day but did not check temperature-no fever as of time reported. Patient developed soreness at site the evening received shot and reports increased pain and swelling as of two days later with the area feeling warm to the touch.
Vaccination adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high.    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 VACCINATION COMPLICATION. The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION  outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  It was reported that patient took cold compresses on an unspecified date.   This case was linked to MOD-2021-370398, MOD-2021-370412 (Patient Link).
No additional AE; administrered of vaccines involved in a temperature excursion; This spontaneous report was received from medical assistance and refers to a patient of unreported age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 16-FEB-2022, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally (lot number 1742467, expiration date: 05-OCT-2022, vaccination scheme, and anatomical location of vaccination were not reported) for prophylaxis. Medical assistant reported administration of vaccines was involved in a temperature excursion(Product storage error). The vaccine was stored for the time frame of 1 hours in the temperature of 1.35 C. There was no previous temperature excursion.  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.  This adverse event report is 1 of the 3 adverse event.
Developed skin erythema on site of injection 2 days after, then progress to blister, scabbing and scarring.
Information has been received from a medical assistant for HPV vaccine, a Pregnancy Registry product, concerning a 15 year old female patient with no drug reactions/allergies and a history of miscarriage on unspecified date (in February), who on 04-JUN-2012 was vaccinated with the first HPV (dose and route not reported) (lot number 672233/1561AA, Exp: 26-AUG-2014). There was no concomitant medication involved. The reporter stated the patient came in for physical and then received the HPV vaccine. Later in the physical, she was given a pregnancy test and learned she was pregnant. The reporter stated she did not plan to receive the rest of the HPV vaccine. There was no treatment given for an AE. Laboratory diagnostic studies were performed: urine pregnancy test. The patient sought unspecified medical attention. Follow-up information has been received from licensed practical nurse via Pregnancy Questionnaire. The nurse provided following information about the patient, date of last menstrual period: 20-APR-2012 (EDD would be on 25-Jan-2013), no birth defects occurred in previous pregnancy and laboratory diagnostic HCG test was performed to confirm pregnancy 9reason for test  sexually active). Follow-up information has been received from a nurse stating that on an unknown date the patient delivered a full term normal and healthy baby. There were no problems and everything was fine. No further information is available.
Severe bruising along arm. Swelling in armpit and at elbow. Started 1 day after IZ (10/10/15).
Patient received ZOSTAVAX 2 days later she came into the pharmacy with a quarter sized rash at the injection site. She complained of intermittent itching.
Large red, burning itching, scaly lesion on right thigh. Lasted 5 weeks and took many forms which included large bruise above it. Treated with topical steroid cream (Clobetasol Propionate) which did not help at all.
A few days after I had this vaccine I developed a chronic dizziness.  I went to my doctor and they did the following tests, over 2 to 3 weeks:  Brain MRI, EKG, and blood work.  All were normal.  I am trying to think of what I may have possibly done different and the only thing is getting this vaccine.  The dizziness is triggered by movement, such as driving and walking.  As a result, I am unable to go to work.  I am out of sick days, after this week, and will soon be unpaid for this time.   I am also having headaches with the dizziness but the primary debilitating effect is dizziness.  It is highly frustrating and entirely nonsensical, as I have never experienced this before.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that the patient received an expired dose of ZOSTAVAX, lot # J008432, expiration date 11-OCT-2014, 0.65 ml, subcutaneous on 24-OCT-2014. No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a female patient of unknown age regarding herself. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, subcutaneously, that according to the patient the healthcare provider did not immediately administered the vaccine after reconstitution. The patient stated they were concerned as the vaccine was left out at room temperature for 40 minutes before being given (product use issue) (dose number, dose, frequency, lot number and expiration date). No product quality complaint (PQC) was involved. Concomitant medication was not provided. Finally, the reporter inquired about the stability information for PNEUMOVAX23, as she thought the vaccine may have lost its potency. Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of delusion in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced delusion, erythema of extremities and adverse reaction. On an unknown date, the outcome of the delusion and erythema of extremities were recovered/resolved and the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the delusion, erythema of extremities and adverse reaction to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient experienced a red band on the arm that lasted a week, including the general adverse events as described in the label. However, the concerning adverse event was he was slightly delusional for around 8 hours on the second day.
Just wanted to report a very long time with soreness at the site of the injection. It has now been a week and it is still tender.  Maybe this is normal for J&J but it would be nice to have that listed.
My son suddenly became tired and went to sleep at the park. He developed a 105 fever which lasted 4 days, even when treated every 6-8 hours with Tylenol. He was lethargic and only ate and drank tiny amounts during this time. The advice nurse told me over the phone to put him in a short sleeve onesie and give Tylenol every 6 hours until it broke. Since then, his language regressed, all his milestones have been delayed, he stopped responding to his name and making eye contact for a year. When I saw his doctor 3 months later I was told these are normal side effects and are not worthy of reporting. After over a year, I still feel strongly this was an adverse event that has affected him despite the doctors casual attitude.
Two days after being giving combination of the flu, COVID, and Tetna Shot, I was having swelling in the right arm where I had the Tetna shot at, and then I started getting fatigue during normal daily activities like a week or two after the vaccine, and that continued after months and I also had a racing heart with little to no activity, my heart beat would 170 without me doing any walking.  If I did any activity I would need to sleep for a day or two just to recover.  This has lasted for the last three weeks and is ongoing. Will be making an appointment with my Dr. after I come from traveling. I spoke to my GYN Dr. which I had to see for a different reason and she informed me that this could also be the result of me having COVID-19 which I contracted in June with very mild symptoms like a cold.
had shot later got shingles/suspected vaccination failure; shingles; painful; This serious 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, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot later got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-MAR-2023 The case was received from the patient interactive digital media. The patient had the shot for shingles and 3 months later he/she got shingles. The patient told that it was painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient came to pharmacy to report a rash on right arm in area where she had the Covid-Pfizer vaccine.  She takes a daily antihistamine for allergies and she had tried a cold compress on the rash.  It has not improved.
A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use). On 04-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
Seen 5/12/12 c/o swelling (L) arm since immunization 5/10/12, fever & chills, myalgia (L) arm (L) side back. Treated with ATARAX PO, Triamcinolone cream topically, elevate arm, cool compresses & TYLENOL PO.
We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning) 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)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Dec-2022, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning) 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 (We had some doses of Moderna bivalent that had a fridge expiration date of 12/14/22 (we don't have ultra-cold storage) and one was mistakenly given to a patient this morning).    No concomitant medications were reported.  It was reported you receive any other vaccines in the 4 weeks prior to COVID-19 vaccine as unknown.  No treatment medications were reported.
A little over 1 month after vaccination, 5-21-2022, I started feeling cold symptoms such as runny nose, cough, severe headache, congestion, sore throat and body aches. I took a home Covid test on 5-21 and 5-22 and both were negative. I also took a home test on 5-23 and it was positive. I had a telehealth visit with the doctor on 5-23 and they prescribed Paxlovid. I have started taking it and I am feeling much better. I am reporting a breakthrough case of Covid.
Initial report received on 29 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL: lot number C3294AA on 10 December 2009, lot number C3541AA on 26 January 2010, lot number C3555AA on 30 April 2010, and lot number C3815AA on 12 April 2011 (routes and sites of administration not reported). The subject developed a cough on 27 August 2012, approximately 16 months after the last dose. Nine days later, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and apnea (onset dates not reported). Laboratory testing included positive PCR on 12 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Asymptomatic covid positive on 12/28/2020 found on routine testing. Had been  tested twice a week for several weeks for covid on routine surveillance. first test  after covid vaccine positive. was negative for covid when tested on 1/4/2021 and  1/6/2021. con  Narrative:
Moderna COVID-19 Vaccine EUA. Right elbow and about 5 inches below elbow are generally swollen with a separate swelling inside the swollen area that looks like a cyst.
Evening of 16 January patient with no family history and no recent trauma, suffered seizure resulting in emergency transport to ER. Event was preceded by extreme lethargy & confusion. All  blood work was clean, blood sugar was normal, no infections, no pregnancy, no drug or alcohol use. CT was ran, results on file ER.
Bell's palsy; she got shingles,They were in her mouth,ear and the back of her head.; she got shingles,They were in her mouth,ear and the back of her head.; "she got shingles,They were in her mouth, ear and the back of her head."; Terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), oral herpes zoster, shingles and pain. On an unknown date, the outcome of the bell's palsy and pain were unknown and the outcome of the herpes zoster otitis externa, oral herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy, herpes zoster otitis externa, oral herpes zoster, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comments: This case was reported by a patient's child via interactive digital media. The patient got the Shingles shot and the week before her second one she got shingles. They were in her mouth, ear and the back of her head.  The patient was still trying to get over them. The patient also got Belles Palsy from them. The patient was in terrible pain.  The reporter stated that hope the patient feel better soon. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Extreme swelling of lymph nodes under arm of left arm - injection arm. Swelling painful to the touch all down left side but specifically in armpit was much worse. Lasted about 5 days - actually took 2 days sick time due to effects of shot.
fatigue; headaches; 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 FATIGUE (fatigue) and HEADACHE (headaches) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and HEADACHE (headaches). At the time of the report, FATIGUE (fatigue) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.