chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dry retching; Slept for about 18 hours; continue to felt ill; Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches; Headache; Profoundly fatigued; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of RETCHING (dry retching), HYPERSOMNIA (Slept for about 18 hours), MALAISE (continue to felt ill), MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for Flu prophylaxis.    No Medical History information was reported.   On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced RETCHING (dry retching), HYPERSOMNIA (Slept for about 18 hours), MALAISE (continue to felt ill), MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches), HEADACHE (Headache), FATIGUE (Profoundly fatigued) and CHILLS (Chills). The patient was treated with ACETAMINOPHEN for Headache, at a dose of 1000 milligram. At the time of the report, RETCHING (dry retching) had not resolved, HYPERSOMNIA (Slept for about 18 hours) and CHILLS (Chills) outcome was unknown, MALAISE (continue to felt ill), HEADACHE (Headache) and FATIGUE (Profoundly fatigued) was resolving and MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient received bivalent Moderna booster shot on the afternoon. This shot was given approximately 1 minute after the seasonal flu shot was administered.  Approximately 2 hours after vaccine administration patient experienced adverse events. Patient continue to felt ill, but am well enough now to get up and self-report.  While the fatigue was ongoing, it has improved significantly. The muscle aches have subsided. The headache was ongoing but responds to 1000mg acetaminophen.   This case was linked to MOD-2021-375334 (Patient Link).   Reporter did not allow further contact
Tdap given 6/8/07. 6/9/07a.m. arm sore at injection site. 6/9/07 p.m. soreness turned to burning and moved distal to injection site down to elbow. Upper arm red, hot, burning, swollen from below inj. site to elbow. Chills 6/9/07 night. 6/10/07 arm same, no chills. 6/11/07 and 6/12/07 less soreness, less redness, less swelling each day but arm symptoms still present. Did not wish to take any Tylenol or Advil or generic of same. 6/12/07 Returned for assessment where vaccination had been given. Assessed by Registered Nurse. She knows she can, for comfort, use ice or heat 15 minute maximum length, and not placed directly on skin. She will see her personal physician if symptoms do not continue to improve or if concerned.
This spontaneous report was received from a lead medical assistant refers to a 25 year old female patient. On an unknown date in 1998 the patient was vaccinated with RECOMBIVAX HB (dosing regimen and frequency unknown) (also reported as complete series) (lot number and expiry date unknown) for an unknown indication. On an unknown date in 2012 the patient received another two injections of RECOMBIVAX HB (dosing regiment and frequency unknown) (lot number and expiry date unknown) for an unknown indication. No concomitant medications were reported. On an unknown date patient was tested for surface antibodies and results were negative. The medical assistant clarified the laboratory testing was the hepatitis surface antigen and not the hepatitis surface antibodies. On 14-JUN-2014, patient was given another dose of RECOMBIVAX HB (dosing regimen and frequency unknown) (lot number and expiry date unknown) for an unknown indication. No adverse events were reported. No product quality complaint (PQC) or Insertion and Removal Related Events (IRRE) was reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. Additional information has been requested.
Joint aches; Fever; Chills; No energy/ weakness; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Apr2021 at 08:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. 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. On 12Apr2021 at 08:30, the patient experienced joint aches, fever, chills, no energy/ weakness and dizziness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events joint aches, fever, chills, no energy/ weakness and dizziness was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Severe muscle soreness left hip & thigh; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 at 12:45 (at the age of 47-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 23Apr2021 at 12:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received medication (unspecified) within two weeks of vaccination on an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 10:00, the patient experienced severe muscle soreness in left hip and thigh. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe muscle soreness in left hip and thigh was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
patient only received liquid portion; patient only received liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMBA5808, expiry date 31st August 2022) for prophylaxis.   On 25th August 2021, the patient received Menveo. On 25th August 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient only received liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt came to immediatley, temp 97.2   bp:110/54   pulse:66  yellow liquid dripped out of nasal passages
Patient received dose 1 of the pfizer covid vaccine on 1/22/21 and dose 2 on 3/4/21. Patient was diagnosed with COVID on 4/22 at outside clinic after presenting with about a week of cough, nausea and fatigue. On 5/2/21 she presented to our emergency department with persistence of the above symptoms and hypoxia to the 70s on room air and again tested positive for COVID. Initially required BIPAP then HFNC. She was treated with broad spectrum antibiotics for 7 days and dexamethasone for 10 days. She was offered tocilizumab and remdesivir but refused. She clinically improved and was weaned down to 2L NC w/saturation of 93%. However on 5/13 she acutely desaturated and was found pulseless. Patient was DNR/DNI so was pronounced dead.
Mild to moderate discomfort with movement of arm. Mild warmth to area. SQ induration and firmness of tissue. Interventions: heat / Massage.
48 hr after vaccine PROQUAD developed erythema and swelling of entire anterior thigh. No fever. Tx'd with BENADRYL. No antibiotics used.
Joint pain, headache, muscle ache, chills (flu-like symptoms) started around 7 this morning (10/3), however,  around 10 AM, my left pinkie finger developed symptoms of Raynaud's Syndrome - numbness, turned white, then purple, which never happened with previous Covid vaccines.  I put on more clothes, moved around a lot and made some hot tea and it resolved in about an hour.
Began to experience itching on back and left side that traveled down legs followed by dizziness. Appeared to be very red in the face as well.
30 minutes after H1N1 injectable became dizzy with headache, nauseated and vomiting, could not stand. Transferred to the ER. Dx with benign paroxysmal vertigo. Rx with MECLIZINE and VALIUM, ZOFRAN and VALIUM.
Case number PHEH2012US023053, is an initial spontaneous report received from a pharmacist on 15 Nov 2012. This report refers to 71 year old patient of unknown gender. The patient was vaccinated with MENVEO (batch number: unknown) on an unspecified date. No further information was reported.
Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 09-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1610USA011133: US-009507513-1610USA011245.
COVID-19; COVID-19; bad headache; had loss of smell and taste; had loss of smell and taste; fever 101-102; night sweats; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4251995-00.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization; upadacitinib (RINVOQ), oral (Lot number: 1150526) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown",  SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "recovering" and all described as "COVID-19"; HEADACHE (non-serious) with onset Jan2022, outcome "recovering", described as "bad headache"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset Jan2022, outcome "recovering" and all described as "had loss of smell and taste"; PYREXIA (non-serious) with onset Jan2022, outcome "recovering", described as "fever 101-102"; NIGHT SWEATS (non-serious) with onset Jan2022, outcome "recovering", described as "night sweats". The patient underwent the following laboratory tests and procedures: body temperature: (Jan2022) 101-102, notes: fever. The action taken for upadacitinib was unknown. It was reported that, solicited report from the privacy by a consumer of a 49-year-old female with an event of non-serious COVID-19 with Rinvoq (upadacitinib). Pfizer biontech covid-19 vaccine (tozinameran) was also considered as suspect. On an unspecified date in Jan2022, two weeks ago the patient had loss of smell and taste, fever 101-102, night sweats and bad headache. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trial.  Causality for Rinvoq (upadacitinib) The reporter's assessment of the causal relationship for the event(s) of COVID-19 with Rinvoq (upadacitinib) was no reasonable possibility. The reporter's assessment of the causal relationship for the event(s) of COVID-19 with Pfizer biontech covid-19 vaccine (tozinameran) was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, lack of efficacy ,anosmia, ageusia, headache, pyrexia, and night sweats of the suspected vaccine BNT162B2 cannot be completely excluded.
Unable to sleep at all; Way too much energy/beyond wired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep at all) and ENERGY INCREASED (Way too much energy/beyond wired) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced INSOMNIA (Unable to sleep at all) and ENERGY INCREASED (Way too much energy/beyond wired). At the time of the report, INSOMNIA (Unable to sleep at all) and ENERGY INCREASED (Way too much energy/beyond wired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
On 1/24/01, pt developed flu-like symptoms of headache, stomachache, vomiting. Also complained of stomach pain on and off for the next 30 days. Vomiting lasted only 1 day.
Redness and swelling which began 24 hours after injection and progressed over the next 72 hours.  Associated initially with fever of 101. That lasted 12 hours. Generalize malaise.
Immediately after the vaccine - headache and fatigue that lasted a couple of days. July -It woke me up; not a normal headache. I knew something was wrong. My husband took me to ER and they transferred me to a hospital. I had a subarachnoid hemorrhage in the brain; 3 days ICU -(Neuro ICU) in the hospital. I had to take some kind of medicine. I stayed in ICU for 3 days and then I was there for overnight after that. I went home with medication. Sept 15- back for a check-up and everything looked really - back to the hospital.
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,) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced possible stomach ache. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and possible stomach ache was not reported. This report was non-serious.
Within 5 minutes after receiving the rotavirus vaccine, my son broke out in a horrible full body rash.
Neck pain began on LFT side (where vaccination was administered) 5 days after vaccination. The pain traveled to LFT shoulder and upper arm, then to RT shoulder over next week. 9 days after vaccination. The pain became so acute, I took pain meds for 7 days.
doses administered past published expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past published expiry). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past published expiry) had 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.  It was reported that no patients were immunocompromised and were vaccinated with the primary series over 6 months ago. The narrative stated that Moderna cannot guarantee patients received full protection against the Covid-19 virus on 29-OCT-2021.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: The follow up document was received and Dose 1 and 2 details was added.
I received my second shingle shot Sunday at 4PM. I started feeling some effects within the hour. By midnight I started trembling severely with the chills even though I was under a feather comforter, a wool blanket, a polar tech blanket and I had my mattress heater on the highest setting. I shook severely for three hours.  I did manage to get up at about 4:00 a.m. to get a glass of water but then I could not get up again until 1:30 p.m. Monday.  Then it took about 2 hours for me to not feel as if I was going to pass out when I walked for more than say 10 ft. and nearly lost continuous even after I sat down, unable to stand for ten to fifteen minutes with my head flat on the kitchen table before I could reattempt walking.  I went back to bed at 8:30 p.m. Monday and I slept for 11 hours. The chills returned as I slept to a lesser degree. I had no more chills after this, however, it took four or five days before I returned to relatively normal activity.
Muscle weakness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Stroke.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscle weakness). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) outcome was unknown.            No concomitant medications were reported. The patient's one side is already weak and is now on wheelchair. No treatment information was provided.   This case was linked to MOD-2021-059693 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received on 11-05-2021: No newinformation
30 sec. after shot given, pt. had a 10cm erythematous rxn. with a central wheal at site of injection. After 1 tsp. Benadryl & Ibuprofen, 30 min. passed & pt. had improved, erythema almost completely resolved but wheal still present.
He has three blood disorders; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EN5318) via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EL1283) via an unspecified route of administration on 23Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient who had received his Pfizer-Biontech Covid19 vaccine series but had also received chemotherapy. The patient stated he was calling with a question he cannot get answered anywhere about the Pfizer COVID vaccine effectiveness on a chemo patient and asked if his chemotherapy just finished up would it get flushed out or deemed ineffective at this point. Stated he asked different oncology people and no one can give a definite answer whether he needs another set of Pfizer COVID Vaccines or a booster of the Pfizer COVID Vaccine since he just finished up chemotherapy treatment. The patient asked if there are any studies going on about this or any information at all, any clinical trials underway and there plans to study the vaccine response in this population. The patient was asked for the name of his chemotherapy and stated the chemotherapy treatment was the tricky part and began on 27Feb2021 and he just finished it up on 18Jun2021 and he had three blood disorders and for that they gave him like five different combinations of chemotherapy drip which was pretty complex and stated he had no names of the chemotherapy treatments with him and no lots, expiry dates or NDC numbers to provide because they were all hand mixed by the pharmacy. The patient stated the chemotherapy was an eight hour drip with 5-6 different bags hung during that period and it was very complex and there are not a lot of cases of what he had; caller was asked if the blood disorders were diagnosed prior to him receiving the Pfizer COVID vaccine and stated it took them three months to figure out what was wrong and to come up with a diagnosis but he would say they did not have the diagnosis when it started in January, no further details provided by the caller. Outcome of the events was unknown.  Follow-up attempts are completed. No further information was expected.