chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis, that underwent a temperature excursion of - 14 degrees Celsius to -10 degrees Celsius for a time frame of 18 hours and 17 minutes and the Digital data logger was involved. Concomitant therapies included sterile diluent. No adverse effects were reported and no product quality complaint was involved. This is one of two cases from the same reporter. Additional information is not expected as no consent for follow-up was provided. Sender's Comments: US-009507513-1705USA000915.
Left thigh swelling 2 days post vaccination on 9/10/07 immunizations given. On 9/12/07 seen by doctor and dx as probable Rx to DTaP, Pertussis component.
Two large (approximately 8cm diameter) bright red patches on chest with vesicles and bullae (looks like severe sun burn)
Mom said patient started having bad headache and chest hurting....took patient to ER and ER said patients heart was inflammed
Pain in left shoulder; Pain in my hand; Flu like symptoms; Cough; Feeling weak; Runny nose; A spontaneous report  was received from a Consumer concerning a  74Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pain in left shoulder, Pain in my hand, Flu like symptoms, Cough, Feeling weak and Runny nose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location Right Arm for prophylaxis of COVID-19 infection.  On date, The patient experienced the events Pain in left shoulder, Pain in my hand, Flu like symptoms, Cough, Feeling weak and Runny nose.  Laboratory details were not provided.  Treatment details include Cough medicine (Mucinex) and Vanclox  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Pain in left shoulder, Pain in my hand, Flu like symptoms, Cough, Feeling weak and Runny nose was unknown.  The reporter assessed the event Pain in left shoulder, Pain in my hand, Flu like symptoms, Cough, Feeling weak and Runny nose related to the study drug was unknown.
Had severe muscle aches in back of both thighs and in both arms between elbow and shoulder.  Was so severe that I could barely get up out of a chair or dress myself.  Had to go to Urgent Care.  They did extensive blood work and gave me Prednisone 60mg.  Later went to primary care doctor, and he sent me to a rheumatologist.  I am on 10 mg of prednisone at the present time.
Chills (flu-like symptoms) about 12 ours after injection, followed by nausea and vomiting the following morning.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult female patient of unspecified age. This refers 48 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Sensitivity to light, cough, headache, diarrhea, fatigue, fever-1week
Inappropriate age./an 11-month-old patient was administered a dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30-SEP-2022) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age./an 11-month-old patient was administered a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAY-2023 The vaccine administration facility was the same as primary reporter The reporter did not specify administration date. The reporter consented to follow up. The patient received Kinrix at 11-month-old, which led to inappropriate age at vaccine administration.
left arm pain; fatigue; nausea; mild pain in left shoulder; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (left arm pain), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (mild pain in left shoulder) 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-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, 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 experienced VACCINATION SITE PAIN (left arm pain), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (mild pain in left shoulder). At the time of the report, VACCINATION SITE PAIN (left arm pain), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (mild pain in left shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Within 24 hours of receiving the 2nd dose, I experienced lymph node enlargement under my right arm. Then the lymph nodes were palpably enlarged for 3 months after receiving the 2nd dose. I had a mammogram and ultrasound 3 months after receiving the 2nd dose (April 29, 2021). The only significant finding was an enlarged lymph node in my right breast close to my axillary lymph nodes. I will be going for a follow up mammogram and ultrasound.
Sore arm; fatigue; tiredness; This is a spontaneous report from a contactable pharmacist reported for herself .  A 46-years-old female non pregnant patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, in Arm Left on 27Feb2021 as 1ST DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior to vaccination. The patient did not test for COVID, post vaccination. It was reported that on 01Mar2021, she had sore arm, fatigue and tiredness. Treatment was received for adverse events. Therapeutic measures were taken Tylenol as a result of sore arm (pain in extremity), fatigue, tiredness. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Feeling Sick; Cannot get out of bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Feeling Sick) and BEDRIDDEN (Cannot get out of bed) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid cancer. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, METOPROLOL for Heart disease, unspecified, LEVOTHYROXINE for Thyroid cancer.   On 12-May-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 13-May-2021, the patient experienced MALAISE (Feeling Sick) and BEDRIDDEN (Cannot get out of bed). At the time of the report, MALAISE (Feeling Sick) and BEDRIDDEN (Cannot get out of bed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant treatment medication information provided.
Flu-like Symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced Flu-like symptoms after receiving a dose of Shingrix. The reporter did not consent to follow-up.
Severe muscle aches, auditory, visual and tactile hallucinations, low-grade fever, nausea, headache
An non serious event of vaccination administration error occurred in a fourteen-month-old female.  The report was received from a registered nurse in the USA.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  The reporter indicated the infant has had wheezing issues.  The infant received a one-time dose of Flumist intranasally on 02-Nov-2007.  On 02-Nov-2007 the reporter indicated a infant was inadvertently administered Flumist, the mistake was discovered 30 minutes after dosing.  The administering nurse thought Flumist was indicated for children over 1 year of age; the infant was also reported to have wheezing issues.  The reporter called to check on the infant the day after dosing and no problems had been observed and the family has not contacted the health department to report any adverse effects.  Outcome: the infant had no ill effects.  Further dosing with Flumist is not indicated.  Causality assessment was not reported for this medication error.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored VARIVAX (Merck) (dosing regimen unspecified) (L024252 (also reported as 1024252), exp: 30-JUN-2017). No concomitant medications reported. No adverse effects reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
102 degree fever, body aches, severe chills, lethargy, weakness, muscle aches, fatigue, swollen lymph nodes. Rested in bed for 4 days, felt better on the fifth. I feel an onset of similar symptoms today 03/05/2021, 17 days after 2nd vaccine dose.
Patient was given 1 dose as the bivalent not the primary series. Patient was stable and was not showing any adverse effects. Patient was informed of what vaccine was given and that the patient still needs to complete the primary series.
Information has been received from a consumer concerning his 19 year old daughter with "a problem with penicillin drugs" and no pertinent medical history, who on "late June 2009" was vaccinated intramuscularly with the first dose of GARDASIL, 0.5 ml. Concomitant medication included an unspecified allergy medicine. The consumer reported that on "late June 2009", his daughter felt "woozy" after getting her first GARDASIL dose. The doctor's staff had her lay down after getting vaccinated and when she stood up and she almost fell. She laid down "for a few more minutes" and when she stood up again, the same thing happened. After they had her lay down for a few more minutes, she was able to stand up, but she was really tired for a couple hours. She had not had her second shot yet. The same day, the patient recovered. The patient sought unspecified medical attention. Additional information is not expected.
48 hours after MMR and Varivax - patient has low grade fever 101.4, and left side facial swelling - presumed parotitis.
Projectile vomiting that night of the injection, had 104.00 fever it lasted for 3. I stopped getting my period, and about two months ago I started getting a rash around August, it looked like bruising. I've never had anything like. As of now they only gave me some cream for the rash, and about 60 blood test. No medication was prescribed. I'm still having issues with my period.
Two days post-vax felt muscle/bone pain from elbow to shoulder, shoulder blade and upper breastplate pain. Still experiencing symptoms to date. Have not sought medical attention as of yet.
itchy rashes; rashes; hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives), RASH PRURITIC (itchy rashes) and RASH (rashes) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced URTICARIA (hives) and RASH (rashes). On 19-Sep-2021, the patient experienced RASH PRURITIC (itchy rashes). In September 2021, URTICARIA (hives), RASH PRURITIC (itchy rashes) and RASH (rashes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  On 19-Sep-2021, the patient had itchy rash all over the body.
An 18-year-old female patient, who was hospitalized from 18 July 2008 to 19 July 2008 because she became confused and angry after receiving a first dose of IMOGRAM Rabies-HT and IMOVAX Rabies on 18 July 2008 for accidental exposure to a cat that was known to have rabies. These events are reported in case 2008-02453. The patient subsequently received the second dose of IMOVAX Rabies-HT (lot number, route and site of administration not provided) on 21 July 2008. An unspecified amount of time later, the patient experienced back pain and a headache. It was not reported whether the patient sought medical attention. Six days later, the patient received the third dose of IMOVAX Rabies-HT (lot number, route and site of administration not provided) and again, at an unspecified amount of time later, the patient experienced back pain and a headache. Again it was not reported whether the patient sought medical attention. At the time of this report, it was "unknown" whether the patient had recovered from the back pain and headache The reporter for this case is the same as for case 2008-02453.
Patient had her 2nd Moderma, 4th dose. After booster went down hallway to get an xray an when she layed down on xray table told technician that she felt lightheaded. Fully conscious, able to verbalize symptoms. No chest pain, no shortness of breath. Admits did not eat very much this morning. Declined juice. States will go home and eat something, lives close by. Able to stand, dress and left clinic in stable condition.
Information has been received from an unspecified reporter referring to an 12 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Patient said a rash of 2 to 3 inches occured around the injection sight and lasted for 14 days. Also a month later Patient had 1 or 2 spots of unknown breakouts on her back and wondered if this was causeded by the shot or a moist heating pad she was using for pain relief. Referred patient to her doctor if the symptoms persist.
whole chest hurt, and it felt like the pain was stemming from my chest or my heart more to be exact; I think it was minor heart inflamation; This is a spontaneous report from a contactable consumer (patient).   A 23-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: ER8729) via an unspecified route of administration on 04May2021 at 15:00 (at the age of 23-years-old) in the left arm as dose 2, single for covid-19 immunisation. Facility of vaccination was workplace clinic. The patient medical history included mildly allergic to raw pineapple. Concomitant medications were not provided. The patient previously received first dose of BNT162B2 (Lot Number: EW0161), via an unspecified route of administration, administered in left arm on 13Apr2021 at 15:00 (at the age of 23-years-old) as single dose for covid-19 immunisation with no reaction on previous exposure to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 the patient experienced "my whole chest hurt, and it felt like the pain was stemming from my chest or my heart more to be exact. It was for 3 days after the shot and then it resolved itself on its own. (I think it was minor heart inflammation)". No treatment was received for the events. Outcome of the events was recovered on an unknown date in May2021.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Started with malaise on second day after injection, 4 days after injection started with episodes of sporadic vision loss then floaters severe headaches and then on day 9 after injection severely sick with fever body aches cough congestion and shortness of breath diagnosed with covid 10 days after receiving vaccine and now on day 10 with fever body aches severe fatigue and cough and congestion
After an hour and a half, there was significant swelling below site of injection as well as blotchy rash; some itching. Next morning, awoke with log grade fever (99 f), diaphoresis, intermittent nausea, and extreme fatigue/body aches. At times, felt disorientated while trying to complete mundane tasks.
nausea; weakness; headache; pain; swelling; Health issues; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, for tolerance refer case US2019AMR167033).   On 11th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced nausea, weakness, headache, pain, swelling and adverse reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, weakness, headache, pain, swelling and adverse reaction were not recovered/not resolved.   It was unknown if the reporter considered the nausea, weakness, headache, pain, swelling and adverse reaction to be related to Shingrix.  Additional details were provided as follows: On the day before the reporting date, the patient received Shingrix. The patient had many other health issues and was not sure if this was a reaction to the shot or something else and the patient would check it with primary health care provider. The patient asked about the duration of these side effects and how long they last. The call center representative provided general information of side effects that the patient could experience and also advised to contact primary health care provided. The patient made a call to the primary health care provider and was waiting for a reply.
Around 6/16/08 approximately 2 weeks after dose pt began to have varicella rash on face and around her eyes.  This progressed to trunk and extremities over next few days.  She developed a fever on 6/21 and was admitted at MC for treatment of disseminated varicella infection on 6/21.  Tmax 102.  Pt recieved IV acyclovir and po hydroxyzine for itching. 9/4/08-records received for DOS 6/21-6/27/08-DC DX: Varicella without mention of complications. Presented with 5 day history of generalized body itching and a rash. Itching started in eye then around lips and spread to arm, back and trunk. Rash was pruritic.
Patient received dose #1 on 5/14/21 and dose #2 on 6/4/21.  On 6/30, began to develop petechiae and easy bruising.  Presented to urgent care on 7/3 after biting cheek and a large bruise/hematoma developing on the inside of her cheek.   Thrombocytopenia identified on labs, resolved in 4 days without intervention.
ON 5/20 THE MOM OF PATIENT CALLED THE CALL CENTER AND IT WAS GIVEN TO DR. 16 YEAR OLD WAS GIVEN TO MODERNA. MOM UNDERSTANDS THAT THE 2ND DOES SHOULD BE MODERNA.
A 42-year-old female patient was given tetanus, diphtheria, and acellular pertussis (Tdap) vaccine 0.5 mL on 08/24/2006. On 08/29/2006, the patient complained of chills, goosy flesh, a 3 cm erythematous local swollen left deltoid, and a 2 cm hematoma. No diagnostic testing was done and no rescue medications were given.
pain and soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as a single dose for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain and soreness at the injection site".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning an 8 year old male with no pre existing allergies, or medical conditions who on 10-MAR-2000 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 631469/1346J). There was no illness at the time of vaccination. On 02-AUG-2007, at 10:30, the patient developed a rash, which lasted four days, with a papular lesions and an erythematous base. The patient was treated with Benadryl q 6hours PM. The patient status at the time of reporting was noted to be "unknown". Additional information has been requested.