chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination was administered 11/5/2008, pt presented to the clinic on 11/14/2008 with a rash to the injection site that was diagnosed by Dr. as a local reaction to the flu injection, with no induration. She was given a 7 day course of oral Bactrim. 12/30/2008, mom reported to Dr. that the injection site of flu immunization still looked the same and she wanted to report it to the company.
Over the course of  about 12 hours I experienced  extreme fatigue (sleepy state), muscular pain at the site of the injection, chills, nausea and vomiting, fever and lingering headache.
Rash and hives they started that night and have gotten worse over the past 10 days
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with PROQUAD (lot# L023112 and expiry date: 24-DEC-2016, dose and frequency were unknown), that were improperly stored. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (general fever after the first dose) and headache (little headache after the first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jul 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (general fever after the first dose) and headache (little headache after the first dose). Patient treated with Tylenol (paracetamol) for fever, at an unspecified dose and frequency. At the time of the report, pyrexia (general fever after the first dose) and headache (little headache after the first dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported. This case linked to MOD-2021-300046 (patient link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 12-OCT-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-AUG-2017, the patient was treated by a physician for the onset of a painful papulo/vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX and gabapentin for management of her painful symptoms. As a direct and proximate result of the defective ZOSTAVAX, 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, pain and suffering, and other damages. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced pain, swelling, fever and erythema. On an unknown date, the outcome of the pain, swelling, fever and erythema were recovered/resolved. It was unknown if the reporter considered the pain, swelling, fever and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on unknown deltoid. Limited information was provided by the sales representative from the physician.
Red, hot local rxn. Maximum size 5cm x 6 1/2 cm resolved in 1 week.
broken blood vessel in my left eye; had headaches; arm is still tender; This case was reported by a consumer via call center representative and described the occurrence of broken blood vessel in eye in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant), headache and tenderness. On an unknown date, the outcome of the broken blood vessel in eye, headache and tenderness were unknown.   It was unknown if the reporter considered the broken blood vessel in eye, headache and tenderness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix a week ago and till of reporting patient's arm was tender. On the day of reporting the patient had headaches and awoke with broken blood vessel in left eye. The patient asked are these common side effects.
I took my vaccine around 5pm on Mar 25th 2021 and around midnight 12:30am I experienced severe chills for about 5-7min and then I had to take advil pills and put some 2-3 layers of sweater clothing to get me to normal
Extremely sore mouth; sore tongue; dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-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 in the right arm on 13Apr2021(at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. The patient previously took doxycycline (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On 14Apr2021, the patient experienced extremely sore mouth and tongue and dry mouth. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely sore mouth and tongue, dry mouth was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Ectopic pregnancy in April 2019.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 01-Nov-2021. On 20-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Ultrasound scan: inconclusive (Inconclusive) Inconclusive. On 27-Feb-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Covid symptoms started 04/09/2022; tested positive 04/11/2022. Symptoms were congestion that developed into a cough, fatigue, slight headache, sore throat, and the symptoms lasted for a week, maybe 10 days. It seemed to clear up but then the congestion came back so I don't know if that was new, but the congestion is still ongoing. I did see a Doctor because I'm breastfeeding but they didn't do anything else except a consultation.
Bedtime 10pm started with chills, lasting 4 hours. Next morning woke with body aches , headache and fever, lasting until 3pm
headache; fatigue; chills; This is a spontaneous report from a contactable consumer reporter reported for herself that she received the second dose of COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. The patients past medical history included the first dose of BNT162B2 for COVID-19 immunization. Concomitant medications was not reported. On an unknown date, the patient experienced headache, fatigue and chills. The reporter also stated that her infant son whom she was nursing was irritable on the evening of her second dose. The clinical outcome for the events was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021445201 child
heart started to beat fast; itching; lethargic; hives; rash on my back, forearm and stomach; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart started to beat fast), PRURITUS (itching), LETHARGY (lethargic), URTICARIA (hives) and RASH (rash on my back, forearm and stomach) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to Sulfur derived products).    On 24-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PALPITATIONS (heart started to beat fast), PRURITUS (itching), LETHARGY (lethargic), URTICARIA (hives) and RASH (rash on my back, forearm and stomach). On 25-Mar-2021, PRURITUS (itching) and RASH (rash on my back, forearm and stomach) had resolved. At the time of the report, PALPITATIONS (heart started to beat fast), LETHARGY (lethargic) and URTICARIA (hives) outcome was unknown. 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 did not provide any causality assessments.   No concomitant medications were reported.  Treatment was with Benadryl.
unilateral foot swelling; unilateral foot redness; unilateral foot pain; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017fz1a) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FAMOTIDINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain). On 06-Nov-2021, PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had  test whose result was Normal  Treatment information was not provided.  This case concerns a 40-year old, female subject with no relevant medical history, who experienced the non-serious unexpected events of Peripheral swelling, Erythema, and Pain in Extremity. The events occurred 4 days after the booster dose of mRNA 1273 VACCINE and lasted for 4 days. Diagnostic tests done (C-reactive protein, basic metabolic panel, foot x-ray) yielded normal results. At the time of the report, outcome of the event was Recovered/Resolved. Rechallenge is Not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender's Comments: This case concerns a 40-year old, female subject with no relevant medical history, who experienced the non-serious unexpected events of Peripheral swelling, Erythema, and Pain in Extremity. The events occurred 4 days after the booster dose of mRNA 1273 VACCINE and lasted for 4 days. Diagnostic tests done (C-reactive protein, basic metabolic panel, foot x-ray) yielded normal results. At the time of the report, outcome of the event was Recovered/Resolved. Rechallenge is  Not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.
On the 2nd day after receiving this 2nd dose vaccine, I noticed my right arm felt extra sore, and I was not able to move it upward and back at all, without an intense amount of pain. It has been over 2 months and I am still not able to move my arm/shoulder certain ways, limited use of my right arm, and I also have a constant aching/throbbing in the upper arm and into the shoulder area. I've seen a Nurse Practitioner about it, on 3/31/21.  She had me apply moist heat to the area 3x/day and  Advil every 12 hrs. for 2 weeks.  I followed this but there was no improvement at all. She is now sending me for an MRI and I should have an appt. set up today.
Patient got influenza in (L) arm followed by meningococcal in (R) arm. Pt stated that the (R) arm hurt a bit when getting the shot. Pt seemed fine after both shots initially. A few mins after the shots, pt complained of not feeling well. He then passed out, eyes rolled back & he convulsed. 911 was called. EPIPEN given. Pt then became alert and stayed alert & talking. Pt was seen by PCP. Was told it was probably nerves & not an an allergic reaction.
POSSIBLE TEMPERATURE EXCURSION OF VACCINE AND ADMINISTRATION TO PATIENT AFTERWARDS; This spontaneous report received from a health care professional 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 not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. 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 subject experienced possible temperature excursion of vaccine and administration to subject afterwards. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible temperature excursion of vaccine and administration to patient afterwards was not reported. This report was non-serious.
pt recvd vax 8OCT95 & 24OCT95 pt devel a pruritic vesicular rash w/approx 5 to 6 lesions w/an erythematous base;presented to MD who felt that the rash was consistent w/varicella rash;therapy w/DPH & ATB ointment was initiated for tx;
This spontaneous report was received from an other health professional referring to a 27-year-old female patient. Her concomitant medications and drug reactions/allergies were not reported. Historical drug included GARDASIL. It was reported that the patient when she was 20 years old, received complete 3 dose series of GARDASIL on unspecified dates in the beginning of 2012 for prophylaxis. The reporter also stated that the patient was currently in the physician's office to receive the first dose of GARDASIL 9 for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration were not reported) (product administered to patient of inappropriate age). The patient has not yet received GARDASIL 9 (circumstance or information capable of leading to medication error). No adverse effects were reported. No product quality complaint (PQC) was involved.
He called and said he felt ill.  I said that He should rest and maybe consider seeing a physician.  I told him it was possible that it was coincidental.  He just came in here to show me his arm.  It is still quite red and swollen.
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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
Fever like 102; Chills; A report was received from a physician concerning a male patient who was participating in the mRNA-1273 Emergency Use Program and experienced chills and fever like 102°.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 29 Dec 2020, approximately 0 days prior to the onset of the events chills, and 1 day prior to the event, fever like 102°, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient developed chills following vaccine administration. On 30 Dec 2020, the chills resolved, but the patient reported fever of around 102. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, chills, was considered resolved on 30 Dec 2020. The outcome of the event, fever like 102°, was unknown.   The reporter did not provide an assessment for the events, chills and fever like 102°.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
swelling around left wrist and hand-same arm as vaccine injection site; "a little fever", "felt a little warm.  A little unwell, not that bad"; swelling around left wrist and hand-same arm as vaccine injection site; pain/throbbing pain at the swelling location; A little unwell, not that bad; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling around left wrist and hand-same arm as vaccine injection site. He also said there was pain/throbbing pain at the swelling location. He also had "a little fever", "felt a little warm. A little unwell, not that bad". He did not take his temperature but stated "I took Tylenol and iced swelling location, it helped some. It is not quit as bad today, no more throbbing pain, still swelling and sore". The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Moderate metallic taste in the back of mouth    No treatment needed.  Disappeared after about an hour.
extreme joint pain (*osteoarthritis/osteoporosis, doing PT now, but pain much worse and sudden onset), slight fever, hands and feet very warm, increased tinnitus (*already have tinnitus, but it was worse and quickly)
Hip pain/soreness, right foot arch pain, lower back pain/stiffness, middle back pain and horrible back spasms, stiff neck, neck pain
Morning of day after vaccination had headache, fever, chills, joint pain, muscle aches. 2 days after vaccination same symptoms also diarrhea and positive COVID-19 test.
Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had booster dose six months ago and then had COVID-19 six weeks ago from the date of report. On 11-Jul-2022, the patient received restylane kysse filler in lips. It was reported that patient had lack of effect post filler injection. No concomitant and treatment medication information was provided.  Company Comment: This spontaneous case concerns an elderly female patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 18 weeks after receiving the booster dose of mRNA-1273. The patient received mRNA-1273 as primary series of COVID-19 vaccination but administration dates were not provided. The clinical presentation, diagnostic evaluation including COVID-19 test and treatment information were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred approximately 18 weeks after receiving the booster dose of mRNA-1273. The patient received mRNA-1273 as primary series of COVID-19 vaccination but administration dates were not provided. The clinical presentation, diagnostic evaluation including COVID-19 test and treatment information were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient called and said that she had been having side effects for the 4 months since she received her second vaccine, but she did not give any details.  She said she is going to report to VAERS as well
Mother of patient noticed on Saturday 11/16/19 in the morning when bathing her son that his entire upper arm from the sholder to the elbow was red she says about 6" x 3" just on the top of the arm not under. She said the redness looked like a "sunburn." She said the area was very painful for her son and he would not let her hug him. She said she did not do anything to treat it and did not take him in to the doctor. On 11/18 in the morning she said it was lighter pink and still painful.