chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 61 year old female nurse with drug hypersensitivity to codeine, BIAXIN and sulfa which causes headache, CELEBREX which causes rash, LODINE, and RELAFEN. A history of a severe case of chickenpox years ago, who on 29-FEB-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck). Concomitant therapy included SYNTHORID, VIVELLE, MAXIDE prn, NASONEX, CLARITIN, BENTYL prn, DIFULCAN, glucosamine, chondroitin, calcium (unspecified), vitamins (unspecified) and omeprazole (MSD). On 29-FEB-2008, the patient felt pain during administration of the vaccination and stinging. The patient had more pain at the injection site that same evening. On 01-MAR-2008, the patient experienced chills, nausea, and "didn't fell well." The patient described a 5 inch round raised red reaction at the injection site with a 1 cm raised hard knot where the injection was given (the 1 cm area seemed to be "chickenpox like"). The entire area was hot to touch and tender. The 1 cm knot was a whitish brown color in which a couple inches around the area was hard. There was no medical attention sought. At the time of the report the patient was recovering. The patient stated the reaction seemed to be better because it looked less red but was still warm. There was no product quality complaint involved. No further information is available.
Pt called and stated she had normal reaction of flu like symptoms like she had from her second dose of Pfizer, but she started to have numbness in both of her pinky fingers and and thumbs.   I told her if it continued she could seek medical attention and I would report it.
Vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported.).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Benadryl only one pill.
This spontaneous report was received from a nurse referring to a 8 weeks old patient of unknown gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 20-OCT-2016, the patients was vaccinated with improperly stored dose of ROTATEQ lot # M006112 expiration date 16-NOV-2016 (volume/dose reported as 2) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided The vaccine was purchased with private pay insurance. This is one of the 4 reports from the same reporter. Additional information is not expected because all information required has been received. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA004377: US-009507513-1612USA006675: US-009507513-1612USA006674: US-009507513-1610USA003097: US-009507513-1612USA006676: US-009507513-1612USA006672.
Case number PHEH2014US013874 is an initial spontaneous report received from a nurse on 09 Jul 2014. This report refers to an unknown age and gender patient. Past medical history and concomitant medications was not reported. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: A12125), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on an unknown date in Jun 2014. No adverse reaction reported following this administration error.
Started out pain in both hands by the thumb. Pain then went to my left elbow area, then to my right elbow area.  Started getting into my toes and fingers.
This spontaneous case, initially received on 04-Dec-2017, was reported by other health professional and concerns a 21-year-old adult female patient. On 01-Nov-2017, the patient was administered with FLUVIRIN Thiomersal (batch number: 1721001, expiry date: 31-May-2018, dose, route of administration, anatomical location: not reported) which underwent temperature excursion down to 32 F for 8 hours and 6 doses were administered. It was reported that, the vaccine was stored at 39 degrees and later the temperature was found to be in between 32 and 34 degrees from 9:00 am to 5:00 PM. The temperature was adjusted but, again it went up to 36 degrees. The vaccine was not frozen. It was reported that the patient had no adverse event.
Moderna COVID-10 Vaccine EUA Upper right lips started to tingle and swell, spread to the center upper lips. Took a Benadryl 30 minutes after the symptoms. Woke up the next morning upper lips still slightly swollen and numb. No more tingling sensation. Took another Benadryl. Swelling and numbness is still there
I started getting symptoms in the afternoon. I sit down to watch TV then my throat got scratchy and I felt off. It got worse before I went to bed. Then the next morning my symptoms were worse. I took a COVID-19 home test that was negative. I went to the doctor that day as well and she suggested to come back tomorrow to get a COVID-19 test. So, on 7/20/2022, I had a positive COVID-19 test and I also took another at home COVID-19 that was positive as well. I was called in molnupiravir and I started that dose yesterday. I have a headache, fever, sneezing, and cough.
Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; reported significant body aches.; Nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A contactable Physician reported similar events for fifteen patients. This is 1st of fifteen reports.   A patient of unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received COVID vaccine resconstituted with 1.3 ml instead of 1.8 ml on an unspecified date. It was reported that the patient experienced significant body aches, nausea, vomiting, diarrhea on an unspecified date. The seriousness of the events was reported as non-serious. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.
Hospitalization for shortness of breath due to COVID-19 on dates 8/22/2022-9/1/2022..  Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Patient presented to pharmacy on 8/1/16 with red, circular inflamed area approx 1.5 inches in diameter with scab at center.  Per patient injection site bled after removal of bandaid then scabbed over. No pain, no fever, not hot to touch, no swelling of mouth/tongue/throat.  No treatment sought.
Father specifies that the boy was vaccinated on Saturday October 25 2016. The 4 year old vaccines were administered. On Sunday morning the right arm was warm to touch, swollen and a little red. Today it looks swollen, red and hot to touch.
HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) in a 20-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection). At the time of the report, COVID-19 (HCP explained that 2 female colleagues who've previously had Moderna vaccine(s) had covid infection) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that female patient who previously had Moderna vaccine(s) had covid infection.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-749418 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749418:same reporter/patient 1
full body muscle pain and soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown) via an unspecified route of administration in the right arm on 09Apr2021 at 10:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced full body muscle pain and soreness. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event full body muscle pain and soreness was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had a painful, delayed reaction to the shot...about 2 hours after I received it as I was driving home, I felt a very painful burning sensation that traveled up my arm to my neck and made it so I couldn't drive.  Since then, the arm has been very painful to lift anything heavier than a small bottle of tea, using it to push myself up off the couch or out of the bathtub, laying on it to sleep, reaching for items that are higher than my hips, and other times when I'm not using it.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's concurrent conditions included diabetes. Approximately on an unknown date in 2008 (reported as about six years ago), the patient received her first dose of unspecified Pneumococcal vaccine (manufacturer unknown) (dosing details unspecified) for unknown indication. On 30-JUL-2014, the patient received her second dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (also reported as PNEUMOVAX23) (lot E J015868, expiry date of 25-FEB-2015), 0.5 ml, intramuscular, immunization. Concomitant therapies included metformin and levothyroxine sodium (manufacturer unknown). On 30-JUL-2014, the patient was keeping her arm in the sling because it hurts and arm fatigue. The patient called the pharmacist and reported that she was having a hard time lifting her arm where she received injection. And the patient reported arm fatigue and that she had been keeping her arm in sling because it hurts. No treatment were given for the event. No lab diagnostics were performed. The patient sought the medical attention and she called to pharmacy. No product quality compliant was reported. The outcome of the events was reported as not recovered. The causality of the event was unknown.  Additional information has been requested.
Patient received Heplisav for 3rd dose instead of Engerix. No ADR's after 30 minutes of observation after administration.
Initial and follow up information has been received from a father concerning his 5 year old daughter with a history of ear infection NOS who on 08/29/03 was vaccinated with MMRII, strength of 0.5mL, via SC injection at 2:30PM. The reporter stated that the pt awoke on 08/30/03 with cold like symptoms such as "cough, sore throat, and low grade fever". The pt was treated with Tylenol Cold Multi-Symptom, Ibuprofen and cough patches. The pt's symptoms have worsened. The pt's father did not seek medical attention for his daughter "but will do so".  Follow up information revealed that the pt's father called the pediatrician and he spoke with the NP. The NP did not prescribe any treatment. The cold like symptoms resolved and the cough lasted for one week and then it resolved. The pt did not require a visit to the physician. Additional information is not expected.
Initial non-serious case received from a health care professional on 14 October 2008. A 37-year-old female patient reported symptoms of fever, chills, headache, dizziness, nausea and abdominal pain three days after receiving a subcutaneous left arm injection of JE-VAX (lot number EJN234A). She had no vomiting or rash. Patient outcome reported as 'not recovered'. Follow-up information received on 10 November 2008 from the original reporter who is a health care professional. Per the reporter, the patient was taking concomitant medication FLORINEF (previously reported as "Floranase") at the time of the vaccination on 10 October 2008 for low potassium/sodium blood levels to help with reabsorption of sodium and potassium. The JE-VAX vaccine administered on 10 October 2008 was the first dose the patient had received. When the reporter spoke with the patient on 05 October 2008, the patient reported that she sought medical attention for her symptoms after receiving the JE-VAX vaccine and received help with the symptoms that had persisted including the nausea, vomiting (newly reported symptom) and abdominal pain. The patient stated she subsequently developed gastritis and was hospitalized for treatment. She was later released from the hospital to home and went on leave from work for recuperation. The patient declined to complete the vaccine series. The patient is willing to provide any further details if necessary. The recovery status of the patient was reported as recovered. Per this new information, this case is being upgraded to serious. Documents held by sender: None.
Following OVID vaccine #2 (Pfizer) at 4:30 p.m. on 6/16/21.  Approx 15 minutes after receiving vaccine developed tightness in the chest and throat, racing heartbeat and shortness of breath and was given benadryl 50 mg IV during triage. Then she was treated with solumedrol and Ativan; she remained hospitalized overnight  for observation on telemetry.   *Following Pfizer dose #1 bilateral feet became mottled, and then "completely purple".
Woke up to chills on early morning on 5/9, low grade fever, ache in joints, upset stomach.  This lasted until approximately 10:00 PM on 5/9.  Arm was very sore all day on the day of the vaccine and into the day of 5/9. On 5/11, I woke up to a large red swollen area where the shot had been given.  Arm is sore again.  Swelling around injection site
Case number PHEH2016US029323, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 48 years old female patient. Past medial history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX Quadrivalent at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. The patient was vaccine with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 26 Oct 2016. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 24 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (26Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient underwent COVID-19 Treatment with Paxlovid, treatment start date=17Jun2022, treatment stop date=22Jun2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient reported that he experienced COVID-19 rebound, where his symptoms went away and he tested negative with an at home test, completed the Paxlovid course, and on 26Jun experienced some symptoms and tested positive again. The symptoms ended up worse overall than before treatment (as the treatment was effective in the first place).
Stomachache since 10/11, no emesis, no fever, no constipation, seldom has stomachaches unless eats eggs. Upset stomach-not one sided. Plans to follow-up with doctor today.
SLIGHT PAIN AT INJECTION SITE FOR  30M; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced slight pain at injection site for 30m. The action taken with covid-19 vaccine was not applicable. The outcome of slight pain at injection site for 30m was not reported. This report was non-serious.
2 days after first shot had sore arm, fatigue, headache - nothing unexpected. 3 days after felt perfect, 4 days after hit hard with allergies, partly in time with spring, but more severe than I have ever experience, constant nose drainage that led to intense coughing. Lasted for a month, some improvement after 4 weeks.
Pt received HPV vaccine appeared fine while sibling received vaccine, pt fainted. Fell to floor. Responded almost immediately, bruised arm, no other injuries noted. BP, pulse stable. Released after 15 mins.
redness; swelling; pain to the touch; This case was reported by a consumer and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced erythema, swelling and tenderness. On an unknown date, the outcome of the erythema, swelling and tenderness were unknown.   It was unknown if the reporter considered the erythema, swelling and tenderness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. On Tuesday, the patient received Shingrix and experienced redness, swelling and pain to the touch. This is 1 of the 3 linked cases, reported by the same reporter.
Information has been received through the Merck pregnancy registry from a registered nurse concerning a pregnant 28 year old female who on 03-APR-2007 was vaccinated with a dose of VARIVAX (Oka/Merck).  The patient sought unspecified medical attention.  No adverse reactions were reported.  Follow up information received from the registered nurse indicated that the patient had a positive pregnancy test at home.  Subsequently, the patient experienced some bleedings and had a miscarriage at approximately 4 weeks gestation.  Upon internal review, miscarriage was determined to be an other important medical event.  Additional information is not expected.
vials were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, 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 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again).    Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday as reported from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the health care professional.  This case contains information for patient 73 out of 100 patients reported by the reporter.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case