chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt complained of a stomach ache, and the pt had a temp of 99.8.
This spontaneous report was received from the administrator referring to an unspecified patient (age and gender unknown). No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on an unspecified date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M032649 with unknown expiration date) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine dose was exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes; no digital data logger was involved or previous temperature excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587.
Information has been received from a nurse concerning unspecified patients (age and gender not provided). The nurse reported that since 25SEP2014 improperly stored PNEUMOVAX, ROTATEQ and GARDASIL were administered to unspecified patients. No adverse effects were noted. No additional information was provided. Additional information is expected.
Headache, joint pain, myalgia, tingling, neck pain, jaw/tooth pain, concentration issue/problems neck/back stiffness, flu like symptoms, general unwell feeling.
Patient reported cramping on the left side of her abdomen and is pregnant (around 20 weeks gestation). She had a bowel movement but was still having cramping. Blood pressure was slightly elevated 140's/90's. Patient stated that she "felt hot and shakey." She also had not eaten since early in the morning. The patient was brought to the medic room for further evaluation and was released with no further treatment.
2.5 month old male noted by mother to have prolonged first time generalized seizure with left sided arm twitching. Noted also by paramedics. Taken to hospital, stabilized and transferred to another hospital. Kept until next day for tests. No medications or follow up appointments at discharge except primary care.
My appetite went away; A lot of inflammation in my stomach; Lost weight, around 10 pounds; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTRITIS (A lot of inflammation in my stomach), WEIGHT DECREASED (Lost weight, around 10 pounds) and DECREASED APPETITE (My appetite went away) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced WEIGHT DECREASED (Lost weight, around 10 pounds). On 23-Apr-2021, the patient experienced GASTRITIS (A lot of inflammation in my stomach). In May 2021, the patient experienced DECREASED APPETITE (My appetite went away). At the time of the report, GASTRITIS (A lot of inflammation in my stomach), WEIGHT DECREASED (Lost weight, around 10 pounds) and DECREASED APPETITE (My appetite went away) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Endoscopy: normal (normal) normal.         No relevant concomitant medications were reported.  Treatment medications included unspecified medication for stomach and serum.  DIAGNOSTIC RESULTS  On an unknown date, ultrasound and unspecified tests for bacterial infection: Normal  On an unknown date, Endoscopy: normal   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Event outcome and lab data were provided.
Ached all over, nausea, insomnia, fatigue, and extremely sore arm.  My arm is still very sore and it has been two weeks since the vaccination.
Stomach ache all day, legs ache all day, fatigue, listless, diarrhea at 5:15 PM  On Wednesday still had stomach ache, aching legs, listless, loose stools.  On Thurs. severe stomach pain (took to doctors), bloated stomach, gassy, listless, fatigue, crying/sleeping all day.
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 10-JUL-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:
I have the loss of smell since the first vaccine and it seems to have gotten a little worse since the second on April 6, 2021. I did not lose the sense of smell when I had COVID-19 in November 2020
Time course: morning after injection, severe swelling in injection site, numbness down left side of body, severe headache, sore muscles: full body
injection site swelling after her first dose; 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 female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "spinal cord disorder" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: survivor for 33 years; "Anxiety" (unspecified if ongoing); "Muscle Pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "injection site swelling after her first dose".  Additional information: she also experienced injection site swelling after her first dose. She is taking pain medication, anxiety medication, blood pressure and blood thinner. She is also a breast cancer survivor for 33 years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WEAKNESS, SHORTNESS OF BREATH, NASAL CONGESTION, DEATH Narrative: Patient died after COVID vaccine dose #1 01/07 visit for chemo, stable 01/21 visit for chemo, stable 01/27 hematology visit d/t rash, likely heat rash 02/09 chemo for multiple myeloma, reports fatigue but no dyspnea 02/10 COVID vaccine dose #1 03/02 chest xray with concern for bilateral pneumonia, treated with antibiotics 03/08 pt having pain in back of the neck 03/09 pt having shortness of breath, transported to hospital with persistent generalized weakness with body ache and shortness of breath; diagnosis: atypical pneumonia, viral vs. bacterial, acute dyspnea with hypoxia, nonproductive cough, chest congestion, headache, and malaise 03/25 pt passed away COVID vaccination not likely contributor to patient's death, but is more likely due to advanced age (83 y/o) and comorbidities, especially active multiple myeloma, receiving chemo. No immediate reaction after first vaccination. Hospitalized a month after vaccine and illness persisted, leading to patient's passint. No COVID infection documented.
MMR given 0.5 cc SQ right thigh area with large spontaneous local RXN 10x10cm red, warm area at injection site with raised area. Pt given Benadryl per physician and watched with no further complication after 20 minutes.
Menses following 2nd Covid Vaccine was four days early and was  very  painful (cramps). In general menses have been more painful since getting the covid vaccines and have not returned to normal .
Reaction; Inappropriate Age at Vaccine Administration; This case was reported by a physician via call center representative and described the occurrence of adverse event in a 39-year-old 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, unknown after receiving Shingrix, the patient experienced adverse event and inappropriate age at vaccine administration. On an unknown date, the outcome of the adverse event was recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose at 39 years old which led to inappropriate age at vaccine administration and had a reaction. This was a medication error with adverse event No further details were provided. For tolerance with 2nd dose of Shingrix, refer linked case US2020000969.
Woke up vomiting.  Thought maybe it was something to do with the lobster I had for dinner the night before.  Vomiting continued throughout the day Thursday.  Started to think maybe it was flu bug.  I also had constant headache which I thought was from vomiting but it wouldn't go away.  I had no other flu symptoms though either.  Vomiting stopped on Friday am but nausea continued with headache and is still present today, 01/26/2021.  Nausea is gone now.  No other symptoms or issues.
5/24/13 Cellulitis - Lt upper arm, Afebrile Rx given - KEFLEX 500 BID 10 days started today.
Patient presented with left arm swelling, redness, and warmth. Advised to apply cool compresses and take TYLENOL for pain. PCP prescribed BENADRYL and Prednisone for swelling.
pain in the area of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the area of injection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 041L20A) for COVID-19 vaccination.     no specific medical history was not provided.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in the area of injection). On 25-Feb-2021, VACCINATION SITE PAIN (pain in the area of injection) had resolved.            Concomitant product was reported as vitamins. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information included no new information. FU received for Daughter case
loose stool/watery diarrhea; arm was sore; She felt a little tired that night (23/Jul/2021) and the next day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose stool/watery diarrhea), PAIN IN EXTREMITY (arm was sore) and FATIGUE (She felt a little tired that night (23/Jul/2021) and the next day) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and FATIGUE (She felt a little tired that night (23/Jul/2021) and the next day). On 24-Jul-2021, the patient experienced DIARRHOEA (loose stool/watery diarrhea). On 25-Jul-2021, PAIN IN EXTREMITY (arm was sore) had resolved. At the time of the report, DIARRHOEA (loose stool/watery diarrhea) and FATIGUE (She felt a little tired that night (23/Jul/2021) and the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient did not take  any medication as a corrective treatment.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up information include event myalgia recoded with pain in extremity.
16OCT91 pt recvd flu vax; 20OCT91 very tired, went to bed; 26OCT-27OCT91 worked & started to get hoarse; 28OCT very hoarse w/some myalgia; 30OCT-2NOV91 severe arthralgia, myalgia, hoarse, malaise, fever, chills, cough, pneumonia;
p/vax pt began crying & waking up approx every 2hr;had clear rhinorrhea, had been congested, sneezing & coughing;also had T101.2;taken to MD afeb, fussy, alert & active;pt dx w/viral URi;
Patient received vaccine and immediately began to feel sweaty and light-headed.  She did not faint or lose consciousness.  Patient received an ice pack and some cold water and began to feel better.   Her blood pressure was normal and after about 10 minutes she began to feel like herself again.  There was no sign of anaphylaxis or further respiratory distress.
stomach upset; Lightheaded; This is a spontaneous report from a contactable pharmacist. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3249) intramuscularly into the left arm on 12Jan2021 at a single dose for covid-19 immunisation. Medical history included allergies to dairy and nuts. There were no concomitant medications. The patient was previously administered with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140) intramuscularly into the left arm on 21Dec2020 at a single dose for covid-19 immunization. The patient experienced stomach upset and was lightheaded on 12Jan2021. The patient did not receive treatment for the events reported. Patient was not pregnant. Outcome of the events recovered on an unspecified date.
Treatment: Benadryl IM 25mg, Decadron 8mg IM Patient started feeling tingling in face about 40 minutes after injection, throat was scratchy and felt like closing off air. Tongue felt thick, eyes felt like they were swelling .
Inj (L) deltoid on 9/2/11 - 9/6/11 site is red, raised warm & painful - advised to take oral BENADRYL, ice site off & on - follow up if problems persist.
rash/itching started approx 24 hours ago, initially involving abdomen, extending to genetalia & lower extremities. Currently resolving. Treatment: Benadryl
Rash, Bumps, Swelling, Fever, Itchy (Still going on, as of today 4/25/14.
Severe swelling, and redness at the injection site which lasted for 3 days. Muscle aches, headaches and fatigue lasted 2 days
very high fever 101.7°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high fever 101.7°F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High blood pressure medicines).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (very high fever 101.7°F). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (very high fever 101.7°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.7°f (High) 101.7°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly the patient was receiving high blood pressure medicines (unspecified).
Painless blistering over the injection site that developed two days following injection.  Area was weeping clear fluid for one day.
Pt recvd 3 doses of Engerix-B 5NOV90, 3DEC90, 12AUG91; 9NOV91 it was determined that pt was a non-responder; booster dose was administered 14NOV91; outcome of booster dose is pending as of 3JAN92;
Dose #1 was Pfizer Primary on 11/15/2022. Dose #2 was Moderna Primary on 12/7/2022. No known side effects.
Arm and body pain, tiredness, headache, chills. I called my medical plan that provides a doctor by phone, and when I called the doctor he told me that due to the symptoms it was COVID-19; I had also taken an exam that had come out as Positive. They gave me medicine for congestion and cough; symptoms lasted between 4-5 days.
Vaccination given on 12/2/2022 but it expired on 11/30/2022. Waiting on response from Pfizer if dose needs to be repeated.
PATIENT DEVELOPED WEAKNESS IN PATTERN CONSISTENT WITH BRACHIAL PLEXITIS (RADICULOPLEXUS NEUROPATHY) WITH WEAKNESS IN THE RIGHT MORE THAN LEFT ARM WITH CLINICAL PROGRESSION
Two weeks after I received the second dose I began coughing and congestion, after 10 days I went home from work early. I went in the next morning to be seen by my pcp. She said I  had pneumonia. I was out from work for 7 days. I never fully stopped coughing. then it got worse and worse. I was sent for a stat referral to a pulmonologist. I mentioned to my pcp and the pulmonologist I had been like this since 2 weeks after receiving the 2nd dose. Both did not believe that was the case. I now have asthma and I am on inhalers. I have to go in June for a pulmonary function test. The visit to the pulmonologist was 7 weeks after the first symptoms had appeared.
I have a doctor appointment on this upcoming Tuesday regarding the symptoms I am having. I had bloodwork completed in February of 2023 which showed a slight decrease in kidney function. To help with this, I recently started taking an electrolyte drink to keep me hydrated which helped slightly. I also noticed pain in my chest and shortness of breath which comes and goes. It does not appear to be related to activity. I plan to speak with my doctor next week for a referral to a cardiologist as I do believe there may be something going on with my heart.
Upper arm (at injection site) gradually became itchy starting 3 days after vaccine injection. By the 6th day after injection it was constantly itchy. It woke me up in the night. No rash, just itch.
This spontaneous report was received from a physician refers to a male patient of unknown age who on an unknown date, was vaccinated with 0.65 ml dose of ZOSTAVAX (dose, route and lot number not reported). It was reported that approximately three weeks after receiving ZOSTAVAX on an unknown date, the patient experienced shingles. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional information has been requested.
This spontaneous report was received from a registered nurse regarding a 16 Months old patient unknown gender. The patients' medical history, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patient was vaccinated with improperly stored doses of M-M-R II lot # N024696, expiration date 07-APR-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA000142.
runny nose/My nose was running a little bit; cold; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0164, Expiration date: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included severe allergic reaction from an unknown date and unknown if ongoing history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine. There were no concomitant medications. On an unspecified date the patient experienced runny nose/my nose was running a little bit and cold. The reporter stated that she is scheduled to receive her second dose of the {Pfizer COVID-19 vaccine tomorrow, but yesterday she got wet in the rain, went into job and it was cold in there, and today has a runny nose/. my nose was running a little bit. is it okay to get vaccine tomorrow. Outcome of the events were reported as not recovered at this time of the report.  Information about batch/lot number has been requested.
Patient received a rash to the left arm, chest & neck. The rash wasn't itchy, but had a burning sensation. She took BENADRYL and is doing fine.
Skin hives appear and disappear randomly throughout the day. Appear in lines or as red dots  on various parts of the body.  Skin feels flush, like a sunburn, generally warm feeling across body.  Prescribed prednisone, Allegra and Xyzal. This does not help. Recurring for two weeks, required hospitalization.
This spontaneous report was received from a pharmacist regarding three patients of unknown age and gender. The patients demographics were not reported. The reporter stated that on an unknown date, the three patients was vaccinated with (Oka/Merck) VARIVAX (strength, dose, frequency, dose number, route, product lot #, expiry date not reported) that was improperly stored. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Numbing feeling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbing feeling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbing feeling). At the time of the report, HYPOAESTHESIA (Numbing feeling) outcome was unknown.        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 reported. No treatment information provided.
Fever, chills, insomnia, body ache, headache. Onset approximately 9PM on 4/14 until 2AM on 4/15. Malaise and fatigue with uterine bleeding on 4/15.
Headache, Myalgia, Fever, Diarrhea, fatigue, chills, injection site pain, swelling, numbness Narrative: