chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax on 8/20/98; on 8/21/98 pt exp mouth hurting, swollen lips, mouth, into nose which hindered breathing, right eye swollen shut, swollen genitals (x3-4day); tx=Benadryl
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022 at 8:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022 at 8:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient's ethnicity. No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Was innoculated on 11/13/08 and was seen in sick call by military on 11/18/08. He was sent to hospital for neck stiffness/discomfort, temp 101, body aches legs and lower back, nausea, vomiting.  12/15/08-records received for DOS 11/18-11/21/08- DC DX: Viral meningitis, probably secondary to small pox vaccine. Intractable nausea, vomiting with headache with photophobia. Presented with 2 day C/O headache, nausea, photophobia and intractable vomiting. Temperature elevation, febrile.
Severe vertigo. Nausea and dizziness. I can't sit up or stand. I have made a doctors appointment. Can't get in until 7/21/21. If this continues I will go to ER
Hives all over. I?ll take Benadryl and they go away but then they come right back. Extreme itchiness and occasional sore throat. My PCP is sending a steroid pack to calm them down hopefully
No adverse event Covid 19 vaccine expired 10/27/2022 Given 11-01-2022
On 2/12/2023, patient presented to the emergency department via ambulance from the residential facility for evaluation of altered mental status, and a positive COVID-19 test on 2/9/2023 at the residential facility. In the emergency department, patient was given a COVID-19 NAA test which resulted positive; Her chest x-ray showed mild cardiomegaly without congestive failure; She was not hypoxic; Her CT abdomen/pelvis scan showed mild bibasilar opacities and small effusions. Patient was treated with a single dose of remdesivir pending a SARS CoV-2 IgG antibody result. Patient was diagnosed with COVID-19 infection, sepsis, severe dehydration, acute kidney injury on chronic kidney disease, and altered mental status. Patient was admitted to the hospital for further evaluation and treatment. Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital:  local Hospital,   Please note that the patient completed the initial COVID-19 vaccine series plus 4 booster shots. Two of the four boosters that she received were the Moderna Bivalent Booster ? administered on 11/9/2022 (Lot number 062F22A) and on 12/13/2022 (Lot number not provided) by a pharmacy. It is unclear why the patient was given a second bivalent booster. Submitter does not have access to further vaccination information on this case. If more information is needed, please contact the vaccinating pharmacy:  pharmacy
Chest pain (began 6/7) that increased over the course of the day until it was so severe I could barely breathe or move. Went to ER by ambulance. Diagnosed with pulmonary embolism with infarct, left lower lobe. Given blood thinners - injection for 5 days, then oral. Still on oral blood thinners. A week later, on 6/15, I returned to the ER after coughing up blood and having pain on the right side of my chest. No PE on that side, but there were signs of fluid and atelectasis on that side. I continue to have chest pain on both sides (left and right) of my chest.
shigles outbreak; generalized pain; rash on groin and lower back; This case was reported by a lawyer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, generalized aching and rash. The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles, generalized aching and rash were unknown.   It was unknown if the reporter considered the shingles, generalized aching and rash to be related to Shingrix.  The initial information was received on 24 February 2021 via medical record (case is medically confirmed). The patient ingested shingrix vaccine. As per pharmacy record, on 24 September 2020 patient dispensed shingrix vaccine. The patient  generalized pain after getting shingles vaccine at pharmacy. Began night of vaccine left arm pain which generalized to whole body ache Subsequently develped rash on groin and lower back. The diagnosis was Shingles outbreak.
Arm started to go warm, skin is blotchy red, feel swollen and is itching a lot.
swelling in her eyes; soreness in her left arm that extended up into her neck.; soreness in her left arm that extended up into her neck.; This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th June 2021, 5 days after receiving Shingrix, the patient experienced eye swelling, neck pain and pain in arm. On an unknown date, the outcome of the eye swelling, neck pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the eye swelling, neck pain and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient for herself. Consumer report that after received her 1st dose of Shingrix the patient started experiencing soreness in her left arm that extended up into her neck.  The patient also had swelling in her eyes. The reporter consented to follow up.
Hot to touch at site of injection; Injection site developed hard area; Swollen at site of injection; Red at site of injection/Increased redness at site of injection; Painful at site of injection; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at site of injection), VACCINATION SITE INDURATION (Injection site developed hard area), VACCINATION SITE SWELLING (Swollen at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection/Increased redness at site of injection) and VACCINATION SITE PAIN (Painful at site of injection) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LANSOPRAZOLE for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at site of injection), VACCINATION SITE INDURATION (Injection site developed hard area), VACCINATION SITE SWELLING (Swollen at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection/Increased redness at site of injection) and VACCINATION SITE PAIN (Painful at site of injection). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at site of injection), VACCINATION SITE INDURATION (Injection site developed hard area), VACCINATION SITE SWELLING (Swollen at site of injection), VACCINATION SITE ERYTHEMA (Red at site of injection/Increased redness at site of injection) and VACCINATION SITE PAIN (Painful at site of injection) outcome was unknown.            Concomitant medication also included Antihistamine for an unknown indication. Treatment medication included Tylenol, Aleve and Ice pack.   This case was linked to MOD-2021-103133 (Patient Link).
Flushed scalp and face; lightheadiness; scratchy throat; This is a spontaneous report received from a contactable consumer (reporting for himself). A 72-year-old male patient received second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration in Arm left on 05Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included High blood pressure and asthma. Concomitant medications included bisoprolol; tamsulosin hydrochloride (FLOMAX RELIEF); omeprazole (PROTONIX) and spironolactone. The patient previously took amoxicillin, levofloxacin, clarithromycin, sulfamethoxazole and experienced drug hypersensitivity for all drugs and first dose of BNT162B2 received on 15Jan2021 10:45 for COVID-19 immunization. It was reported that on 05Feb2021 11:00 patient experience Flushed scalp and face, lightheadiness, scratchy throat. As result visited to doctor or other healthcare professional office/clinic visit and treated with Benadryl. The outcome of all events was unknown.
Pt given flu shot on Dec. 2nd and developed significant knee swelling hours after the vaccine. Pt continues with arthropathy and limp. Per 60 day follow up report-probable pareci Articular juvenille rheumatoid arthritis diagnosis.
Pt had headache start about 20 min after vaccine, continued for 2-3 weeks mild/mod pain has continued 18 days after
deep aching pain in arms & chest & muscle in legs & temp over 101.2;it felt like head was on fire, & was cold @ the same time
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: The reporter was the patient's friend. The age at vaccination was not reported. The patient after vaccination with SHINGRIX experienced a very bad reaction. The caller wished to remain anonymous and declined to provide specifics regarding the patient. The reporter did take down the GlaxoSmithKline response center phone number, to give to the patient, so that she could call and provide the details for the events she experienced. The patient has denied permission to contact their physician.
Second Boostrix on 20Jan2023; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HX952, expiry date 4th May 2025) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 20th January 2023, the patient received Boostrix. On 20th January 2023, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The nurse reported that patient received the first dose on 28 December 2022 and second Boostrix vaccine on 20th January 2023. The reporter consent to follow up. Additional supportive information: The patient received 2nd dose of boostrix, which led to extra dose administered.
Swollen lymph nodes; vomiting; severe headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 31-years-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 14:00 (Lot number: F48030) at the age of 31 years as DOSE 1, SINGLE for covid-19 immunization; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 24Nov2021 (Batch/Lot number: unknown) as DOSE 1, SINGLE for immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Nov2021 14:30, outcome "recovering", described as "Swollen lymph nodes"; VOMITING (non-serious) with onset 25Nov2021 14:30, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 25Nov2021 14:30, outcome "recovering", described as "severe headache". Therapeutic measures were not taken as a result of lymphadenopathy, vomiting, headache.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
POSITIVE COVID-19 TEST; This spontaneous report received from a patient concerned a male of unspecified age. 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 was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On 16-APR-2021, the subject experienced positive covid-19 test. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid-19 test was not reported. This report was non-serious.
Information has been received from a physician concerning an "adolescent" female who was vaccinated with VARIVAX (Merck) (Lot# unknown). Subsequently, the physician reported that the patient received a dose of VARIVAX (Merck) and had an immediately reaction. The area where she received the shot became red. At the time of the report, the patient was recovered. The patient did not seek medical attention. Additional information has been requested.
The pt experienced a fever of 102 - 103.5. 12 hours post vax, the pt experienced a rash on the face and legs. Parents reported symptoms on 6/4/01.
Swelling of arm, muscle ache and pouch developed (fluid like) and then proceeded to have skin turn red.  Pouch proceeded down arm and is continuing  on day 3
Patient received the Pfizer covid-19 vaccine and during the 15 minute observation time began having a seizure. EMS was called and picked patient up and took them to the ER patient came to and was conscious before leaving the store with ems.
Pt woke with swelling of lips and face morning after first injection. 1 week later had severe redness, swelling, and heat of ears
Severe rash and hives until 1/17/22 severe itching and breakout treated with Pepcid 10 mg bid Zyrtec 10 mg bid Atarax  25 mg tid pen Montelukast qd 2 rounds of prednisone Strongly severe  1/9/22-1/15/22
This spontaneous report as received from a healthcare worker (Certified Medical Assistant C.M.A.) refers to an unspecified number patients of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck), 0.5 ml, subcutaneously, that were improperly stored. Concomitant medications were not specified. The PROQUAD (Merck) was exposed to a highest temperature of 26 Fahrenheit (F) for a total of 24 hours over three different excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 22-JUN-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot# N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Patient reports that on 2-22-2020 she developed a rash on her lip. She does report a history of cold sores. On 2-23-2020 she developed a headache, diarrhea, and fever. She contact our clinic on 2-26-2020 and RN advised patient to be seen for evaluation. Dr saw patient and prescribed valacyclovir 500 mg PO TID for one week.
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 59-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter's address updated.
Headache, Myalgia, TENDER INJECTION SITE-SWELLING AND A KNOT Narrative:
I tested positive for COVID-19 11/27/22. I had congestion, fever, headache, and cough. I called Dr., and he prescribed PAXLOVID. I started taking that on 11/27/22 and finished taking it on 12/1/22. I am feeling better now and tested negative this morning.
Pt received the covid vaccine on 2/4/21 and 2/26/21. On 3/19/21, she presented to the Care clinic with shortness of breath. She tested positive for COVID and was referred to the ED for further care
Slight edema at injection site no erythema, RUE pain, lightheaded. Tx: Benadryl 25mg po q 4-6h. Ice/heat. Tylenol/ibuprofen. Good hydration. Slow recovery.
Pt experienced back ache for approximately 3 days, pt also had a headache. These symptoms were experienced with both doses.
She said she was on the coach for 3 days with severe flu like symptoms. However she also said that her arm at the injection site was swollen and red for 10 days. She said she could move the arm fine. She also said the same thing happens when she gets stung by a bee or a mosquito bite.  She said that she is just really sensitive.
pt recvd vax; pt devel some cough, emesis, diarrhea 12-14 days dec po intake; high fever w/ t 102; inc irritability; tx APAp;
Vaccine was thawed on 4/12/2021. Received in clinic on 4/30/2021 and placed in freezer. Rethawed on 5/12/2021 and given to patient on 5/13/2021.
Information has been received from a RN concerning a 35 month old white male pt who on 18Mar03 in the AM was vaccinated in the left deltoid with a first dose of varicella virus vaccine live (lot 643129/0570M). Concomitant vaccination on 18Mar03 in the AM included a third dose in the right deltoid of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar) (lot 491185). On 17Mar04, the pt developed a rash, temp and congestion. The pt presented at the physician's office with a fever and a rash consisting of a few lesions. The reporter noted atypical varicella through vaccine and breakthrough. The pt was treated with acetaminophen (Tylenol), ibuprofen (Motrin) and increased fluids. Subsequently, the pt recovered. A product quality complaint was not involved. The reporter also mentioned two of the pt's brothers were vaccinated with varicella virus vaccine live and subsequently developed breakthrough (WAES0406USA02726 and 0406USA02727). Additional information is not expected.