chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She has not been doing good; Experiencing a growth near her right arm and under her arm at the site of injection; Experiencing a growth near her right arm and under her arm at the site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (She has not been doing good), PERIPHERAL SWELLING (Experiencing a growth near her right arm and under her arm at the site of injection) and AXILLARY MASS (Experiencing a growth near her right arm and under her arm at the site of injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced MALAISE (She has not been doing good), PERIPHERAL SWELLING (Experiencing a growth near her right arm and under her arm at the site of injection) and AXILLARY MASS (Experiencing a growth near her right arm and under her arm at the site of injection). At the time of the report, MALAISE (She has not been doing good), PERIPHERAL SWELLING (Experiencing a growth near her right arm and under her arm at the site of injection) and AXILLARY MASS (Experiencing a growth near her right arm and under her arm at the site of injection) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication list was not known to the reporter.
6 days after the vaccine injection she had a large red, hot area measuring 60-70mm.  States area is tender and itches.  Advised to use compresses to site.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    This case contains information for the 73th patient out of 77 patients described by the reporter. No concomitant medication information provided. It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information provided.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696122:Master case
his is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0153) at the age of 37 years as dose 2, single and administered in arm left, administration date 09Apr2021 10:45 (Lot number: EW0153) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "allergies: SULFA" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Test Nasal Swab: Result Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) negative; (04Jan2022) positive; (12Jan2022) positive. Facility type vaccine was reported as other. No other vaccine in four weeks and no other medications in two weeks were reported. No follow-up attempts are needed. No further information is expected. Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Fever 102.8 at 5:00 pm day following vaccine. Continued with fever 5/1/09 - sibling sick with otitis started on ZITHROMAX.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient felt lightheaded few minutes after flu vaccine, emt checked vitals, normal bp and pulse. emt  sent pt home after making sure he was ok to go home
This spontaneous report was received from a pharmacist referring to a patient of unknown age or gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. From an unspecified date, the patient had an unknown condition (adverse event) that required a prescription of cyclosporine. At the time of reporting the outcome for the adverse event was not provided. The reporter considered the adverse event to be not related to ZOSTAVAX. Additional information is not expected because there was no consent to contact the reporter.
Within 5 days of vaccine the same severe vertigo experienced during first and second vaccines occurred and lasted 2 weeks.
This case was reported by a other health professional via call center representative and described the occurrence of respiratory symptom in a male patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received SHINGRIX. On 7th June 2018, 1 days after receiving SHINGRIX, the patient experienced respiratory symptom. On an unknown date, the outcome of the respiratory symptom was unknown. It was unknown if the reporter considered the respiratory symptom to be related to SHINGRIX. Additional details were reported as follows: The case was received via click to chat by a Medical Assistant. The age at vaccination was not reported. The healthcare professional stated that the patient had respiratory symptoms. The patient was requested antibiotics one day after receiving the SHINGRIX vaccine. The healthcare professional did not provide any further information.
Pt s/p smallpox vaccination on 13 Jan 05. One week later patient developed red raised rash to surrounding area but denied itching or scratching. Pt presented to me on 04 Feb 05 with continued raised red rash, 4 inches in diameter, with erythematous base. Mild excoriation, no vesicles or pustules. Pt with other skin lesions, consistent with psoriasis.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about an unknown date in 2016, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about later in 2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
4 year - female received shots - 5-24-10 developed fever, hives, nausea & vomiting mild dehydration. Hives started around 5-21 nausea & emesis 5-31-10. Seen ER came to clinic 6-1-10 w/hives, poor oral intake-sent back to ER for evaluation. Tx oral steroids/BENADRYL.
large lump; red; hot to touch; itchy; remaining circle is on her left arm where her prior reaction was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (large lump), ERYTHEMA (red), FEELING HOT (hot to touch), PRURITUS (itchy) and SCAR (remaining circle is on her left arm where her prior reaction was) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-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. On an unknown date, the patient experienced VACCINATION SITE MASS (large lump), ERYTHEMA (red), FEELING HOT (hot to touch), PRURITUS (itchy) and SCAR (remaining circle is on her left arm where her prior reaction was). At the time of the report, VACCINATION SITE MASS (large lump), ERYTHEMA (red), FEELING HOT (hot to touch), PRURITUS (itchy) and SCAR (remaining circle is on her left arm where her prior reaction was) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant and treatment medication were provided   This case was linked to MOD-2021-062275 (E2B Linked Report).; Sender's Comments:  MOD-2021-062275:1st dose
Pt developed erythema and dime size hive to R arm below injection site of MMR. No distress noted. Pt did not show signs of discomfort or itchiness. Primary PCP assessed patient. Observed for additional 15 mins; hive size reduced. Mild erythema still present.
PFIZER-BIONTECH COVID 19 VACCINE EVA Soreness in arm, up neck and into face/temple/cheek and jaw on injection side.  Face /cheek feels sore, swollen and numb- coming from neck, into face, up to temple/forehand, into cheek and jawline.  Is this possible Bells Palsy ?
Patient got the shot Saturday afternoon and felt fine all day Saturday. Sunday 9/22/19 (24 hours later) she started experiencing muscles aches, slight fever of 100degrees, and felt tired.  The injection site was also very sore as well.  She took Tylenol for the pain but also rested.  These symptoms last until Tuesday 9/24/19 when she started feeling better.
8MAY98 c/o possible cellulitis traveling entire deltoid;CT scan & MRI results pending;from f/u 28JUL98 pt recovery status is unchanged from unk;
Skin pale with heat and edema surrounding injection site with erythema ring approx 3-4 cm surrounding pale area appearing 4 days after vaccination to Right deltoid area where Tdap had been administered. Patient states no pain to site now or since vaccination. No fever observed by patient or mother since vaccination. Previous tetanus booster given as DTap per record on 06/08/1999.  Mother followed up with family doctor and was told it was localized reaction and to provide usual comfort measures that are provided for anyone post vaccination.
Dizziness/heart palpitations all over 5 full days with waves of dizziness being the strongest; Nausea; Fatigue; restlessness; anxiety; sleep deprivation; strong and scary dreams; Heart palpitations all over 5 full days; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6206), via an unspecified route of administration in the left arm on an unspecified date in Mar2021 at 13:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unspecified date in Mar2021, the patient experienced dizziness, nausea, fatigue, restlessness, anxiety, sleep deprivation, strong and scary dreams, heart palpitations all over 5 full days with waves of dizziness being the strongest. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events dizziness, nausea, fatigue, restlessness, anxiety, sleep deprivation, bad dreams, palpitations was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
A contract employee came in on 8/18/20 for both an MMR and a Varicella Zoster shot, since he was not immune to Mumps, Rubella nor Varicella when his titers were checked, and he did not have immunization records. After receiving the MMR shot and then the VARIVAX shot, the employee started feeling lightheaded. Had him lower his head down between his knees, applied an icepack to his neck and had him breathe slowly in through his nose and out his mouth. After about 10 minutes, the employee did not feel any better and thought he might pass out, so the RN assisted him to the floor of the clinic and raised his legs up onto the seat of a chair.  A few minutes later, his legs started shaking (tremors).  He stated he had never had a seizure nor this type of reaction.  A few minutes later, his arms then also started shaking (tremors). . All along this RN kept asking if he was experiencing trouble breathing, swelling of his tongue or throat, or itching., which he denied throughout.  RN continued to check his vitals and at 1005: BP (132/80), heart rate (92) and pulse ox (88%). RN called the ER charge RN at 1007, who recommended RN call a MET, which was called at 1008. The MET arrived within a couple of minutes and assessed the EE and took him by wheelchair to the ED.
developed flu like symptoms; This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   In October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient herself was a physician. The age at vaccination was not reported. The patient received a flu vaccine about a month ago, unknown brand and the patient was unsure if she received the vaccine intramuscular or subcutaneous. The patient developed flu like symptoms within hours of receipt of vaccine that lasted for a day and a half then resolved. The patient was premedicated with Tylenol. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020225583:same patient, Shingrix vaccine US-GLAXOSMITHKLINE-US2020AMR226311:same patient, Shingrix vaccine
Since my initial does of the Pfizer Covid Vaccine on 02/07/21 at facility, I have lost my regular menstrual cycle. I received the vaccine the week I should have had my cylcle and it never started. Prior to the vaccine, my menstraul cycle was regular.
Look like chicken pots all over body and itchy; Never had that kind of rash; Had a little tiny bump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (Had a little tiny bump), PRURITUS (Look like chicken pots all over body and itchy) and RASH (Never had that kind of rash) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITINE) for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SWELLING (Had a little tiny bump). On 15-Apr-2021, the patient experienced PRURITUS (Look like chicken pots all over body and itchy) and RASH (Never had that kind of rash). At the time of the report, SWELLING (Had a little tiny bump), PRURITUS (Look like chicken pots all over body and itchy) and RASH (Never had that kind of rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she was taking medication that will end on 4-29-2021. Patient went hospital and received medication .No treatment information provided.
She could not keep her food down for an entire day. She basically threw up within a minute of eating. It resolved after 24 hours, there were no other symptoms which is why I do not think it was the flu.
2/5/2021--Patient came to Center for 2nd dose Moderna COVID-19 vaccine but reports that after his 1st dose he had reaction (chills, headache which are common reported side effects) but he also had his resting HR elevated for about 12 hours to 102 bpm and his normal HR is usually 60. 2/9/2021 1635--Called to f/u with patient regarding his 2nd dose of Moderna COVID-19 vaccine, no answer, left message. 2/11/2021 0924--Patient called back, he reports he is feeling well now after 2nd dose but did have a similar reaction but feels like it wasn't quite as bad. He received his 2nd dose on Fri 2/5/21 around 1600 and reports the next morning his HR was elevated to about 104 for about 4 hours, he also had chills for
Pt developed a moderate to severe case of varicella disease, including but not limited to skin rash, pustuoles and scarring.
This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 57-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of herpes zoster (1st dose received on 7th March 2018, see case US2019GSK009212). On 16th January 2019, the patient received the 2nd dose of SHINGRIX. On 17th January 2019, 1 days after receiving SHINGRIX, the patient experienced feels awful, pain and adverse drug reaction. On an unknown date, the outcome of the feels awful and adverse drug reaction were unknown and the outcome of the pain was recovering/resolving. It was unknown if the reporter considered the feels awful, pain and adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: She was a part of a medical cost sharing group under which vaccines were not covered. The patient did not know how long would the side effects of the SHINGRIX vaccine last. The patient got her 2nd dose of SHINGRIX a day before the date of reporting and got all the side effects. The patient knew it was to happen, but did not remember how long. The patient was glad that they qualified for patient assistance for SHINGRIX. The patient did not think to check prior to getting her doses, so did she still qualify. On the date of reporting, the patient felt awful and said she was experiencing every side effect listed. She did note that the aches were better evening compared to morning.
No additional AE reported; PROQUAD was administered on 08/23/2021 following a temperature excursion; This spontaneous report was received from an officer manager and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, pertinent medical history and drug reactions/allergies was not provided.  On 23-AUG-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, frequency, route of administration and anatomical location were not reported), lot # T034824 (rHA) and expiration date established as 11-APR-2022 (conflicting information, reported as 01-APR-2023) following a temperature excursion (product storage error) for prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of -10.7 degree Celsius for 192 hours.
horrible headache; chills; nausea; up for 3 hours; This case was reported by a consumer via other manufacturer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2021, the patient received the 2nd dose of Shingrix. In November 2021, less than a day after receiving Shingrix, the patient experienced headache, chills, nausea and difficulty sleeping. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the chills and nausea were unknown and the outcome of the difficulty sleeping was recovered/resolved.   It was unknown if the reporter considered the headache, chills, nausea and difficulty sleeping to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's daughter. The age at vaccination was not reported. The reporter stated that her mother received the vaccine and woke up at midnight with a horrible headache, chills, and nausea. The patient was up for 3 hours because of these symptoms.  The patient had a headache the next day as well after vaccination.  The reporter stated that her mother lived in and got the vaccine at a pharmacy.  There was no consent to contact the patient. No Health Care Professional information was provided. No Product quality complaint. No further information.