chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatology Consultation: Pt developed new onset lower extremity muscle weakness and knee pain. Gait was quite wobbly. Pt states this has been progressive over the past week and was admitted two days ago when he presented to the ER for further evaluation. Pt reports knee pains at night which have been quite painful and he describes this as aching but is not particularly bothered during the day. Pt reports some constipation over the past week.Marked weakness of the quadriceps and biceps femoris muscles bilaterally. Other possibilities include Amiodarone - induced neuromyopathy. Renal consultation: over the course of this hospitalization his symptoms have worsened and full evaluation is consistent with Guillain-Barre. I am being consulted for initiation of plasmapheresis. Pt developed the onset of some orthostasis and weakness, symptoms have progressed to marked proximal and distal lower extremity weakness. Pt has noted some paresthesia of his hands ad increasing weakness of his lower extremities. He finds it extremely difficult at this time to get out of bed. It is agreed the pt should be initiated on plasmapheresis. We will arrange to get a subclavian or IJ line placed for plasmapheresis and will use one plasma volume exchange replacing with albumin. Currently he has no evidence for marked pulmonary involvement. We will follow his FVC's. Per 1 year follow up: Pt has recovered.
Day 1 and 2 were fine with no issues.  Day 3 woke up with a subconjunctival hemorrhage on my left pupil.
Pretty bad reaction like most people did, terrible reaction; Not feeling well; Coughing; Fever; Nausea/extreme nausea; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever) and NAUSEA (Nausea/extreme nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported. .  Concomitant products included SIMVASTATIN (ZOCOR) for Cholesterol.    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 VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever), NAUSEA (Nausea/extreme nausea), CHILLS (Chills) and FATIGUE (Fatigue). On 25-Jul-2021, VACCINATION COMPLICATION (Pretty bad reaction like most people did, terrible reaction), MALAISE (Not feeling well), COUGH (Coughing), PYREXIA (Fever), NAUSEA (Nausea/extreme nausea), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-299819 (Patient Link).
Severe muscle aches and pains; exhaustion; severe headache; fever; nausea; chills; This is a spontaneous report from a contactable consumer. A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 14:00 (at the age of 37-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 04:00 PM (at the age of 37-year-old) covid-19 immunization. The patient had no covid prior vaccination. On 12Mar2021 17.00, the patient experienced severe muscle aches and pains, exhaustion, severe headache, fever, nausea, and chills that prevented the person from carrying on daily activities for about 24 hours. The patient received treatment with Advil. It was unknown if covid tested post vaccination. Outcome of the events was recovered in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient contacted the pharmacy on Monday 3-6-23 in the morning. She stated that she had a reaction to the Shingrix vaccine on the day following vaccination (3-4-23).  She had redness, fever in the arm, and soreness.  She stated there was no itching or knot felt in the Shingrix injection site. She stated the arm that received the Tdap (Boostrix) was not sore at all and did not cause any reaction.  By 3-6-23 the patient said the soreness had improved and she "just feels really tired." She has relatives that are nurses who monitored her condition. She did not feel the reaction was serious enough to seek medical attention but wanted to inform the pharmacy of the reaction. I asked if she had tried anything to make it feel better and she said she had not. I recommended she try to put ice on the injection site in 15 minute increments and apply some hydrocortisone cream to help with the redness. I asked her to contact me if there where any changes in her condition. On 3-7-23 I contacted the patient to check on her status. She said the arm was no longer sore today and the redness was fading. She said she felt fine, just tired but really ok. She stated she would let me know if there are any changes to her condition as recommended previously.
Incorrect site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect site of injection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect site of injection). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was provided.
Greater than 35 days between Moderna Covid-19 vaccinations; Dermatologist diagnosed her adverse reaction from 29MAR2021 as Covid Arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19 vaccinations) and VACCINATION COMPLICATION (Dermatologist diagnosed her adverse reaction from 29MAR2021 as Covid Arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Dermatologist diagnosed her adverse reaction from 29MAR2021 as Covid Arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19 vaccinations). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19 vaccinations) had resolved and VACCINATION COMPLICATION (Dermatologist diagnosed her adverse reaction from 29MAR2021 as Covid Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
cerebrovascular accident; encephalopathy; dysarthria; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult, female patient (pt). No information was provided regarding the pt's medical history, concurrent conditions or concomitant medications.  On or about 05-MAY-2016, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date (reported as subsequently), the pt experienced cerebrovascular accident, dysarthria and encephalopathy and was treated for the events by a healthcare provider.  The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of cerebrovascular accident and encephalopathy were determined to be medically significant.
achy type; off for a day or two; felt miserable for a day or two; headache; muscle aches, body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy type), MALAISE (off for a day or two), FEELING ABNORMAL (felt miserable for a day or two), HEADACHE (headache) and MYALGIA (muscle aches, body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient stated he has a lot of medical issues.    On 02-Nov-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy type), MALAISE (off for a day or two), FEELING ABNORMAL (felt miserable for a day or two), HEADACHE (headache) and MYALGIA (muscle aches, body aches). At the time of the report, PAIN (achy type), HEADACHE (headache) and MYALGIA (muscle aches, body aches) outcome was unknown and MALAISE (off for a day or two) and FEELING ABNORMAL (felt miserable for a day or two) had resolved.            No concomitant medications were reported.  After the first booster taken on 02Nov2021, he stated he was off for a day or two. He felt miserable for a day or two. He was fine the third day. He talked to his physician and they were scheduling him to get his second booster dose next week.  No treatment information was provided.   Reporter did not allow further contact
Abnormal heavy menstrual flow.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 12:00 (Lot number: FC3183) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gluten" (unspecified if ongoing). Concomitant medication(s) included: TDAP; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0121, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Aug2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 03Nov2021, outcome "unknown", described as "Abnormal heavy menstrual flow.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient reported other vaccine in four weeks. The other vaccine 4 weeks product like TDAP. Other medications in two weeks were Daily vitamins and Zyrtec. Prior to vaccination, was the patient diagnosed with COVID-19 was as No. Since the vaccination, has the patient been tested for COVID-19 was as Yes  No follow-up attempts are possible. No further information is expected.
Last night my stomach twisted around I couldn't turn over; Nauseous; Tired; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration in Jun2021 (Batch/Lot number: unknown) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced last night my stomach twisted around I could not turn over, nauseous, tired and dizziness in Jun2021. It was reported that patient was wondering, does it take, patient got the first shot 6 days ago and was feeling nauseous and tired and enquired is it usually take that long for effects to come. The patient stated feeling nauseous, last night the stomach twisted around and could not turn over. The patient had to hold by the stomach and turn self over thats over. The patient was wondering if thats part of the symptoms of the shot and also had like dizziness this is the 6th day since patient got the shot. The patient enquired if thats part of the shot and does it take a week for symptoms to effect and wanted to know that it take 6 days to get the effects of the shot and also stated that patient do not have the card and got a paper they gave at the store. Consumer hung up abruptly. Hence, limited information available over the call. The outcome of events last night my stomach twisted around I could not turn over, nauseous and tired was unknown. The outcome of event dizziness was not recovered.  Follow-up attempts are needed; information about lot/batch number has been requested.
lips were tingly, rapid heart rate, elevated BP, heart palpitations.  all symptoms improved other than heart palpitations
Patient complained of generalized itching, metallic taste in mouth, nausea and tachycardia. Patient reported cellulitis at the administration site following first dose of Moderna. Patient transfered to ED for evaluation.
Post injection symmetrical intermittent paralysis of arms & legs x 2 x10 min. Then 7d of encephalopathy, sl fever, generalized global slowing of speech, thinking & motor function.
pt recv vax & exp itching & a generalized rash; pt was vax w/2 more doses & the itching & rash recurred p/each dose; No further details were provided;
After receiving the second shot at approximately 1030AM, I returned home and felt fairly normal. In the evening, I started to feel very weak and developed a fever of 101.9 and took 500mg tylenol and continued to hydrate with water and powerade. Throughout the evening, I checked my temperature, it ranged from 101.9-102.8. I also developed strong chills, which caused me to shiver to the point where my significant other thought I may be seizing. (this also happened with the first shot - fevers and chills). I went to bed, waking up 3 hours later and I had to change my pajamas as I was soaked in sweat. I became nauseous and vomited a decent amount of what appeared to be red blood - but did not want to go to the ER as I was cold and exhausted and extremely feverish. Throughout the next 36 hours I continued to run a fever and struggled to do basic household chores (wash a dish, walk up and down the stairs, change shirts, etc) without assistance - normally not things I would need help with. Having had COVID nearly 90 days ago, the aftermath of the vaccination was worse than the actual illness for me.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (Reference number- 00525656) and transmitted to company on 18-Mar-2021.  This case involves a 45-year-old male patient who received an expired 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA and expiry date: 17-Mar-2021) via an intramuscular route in the left deltoid for prophylactic vaccination on 18-Mar-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swollen, reddened, tender at and around injection site. Warmth to touch.
Currently around 60 hours from onset of symptoms. Fever peaking at 102 around 36 hours from start of symptoms; returning to 98.6 after 48 hours. Vomiting and diarrhea began at the onset of symptoms as well. Vomiting stopped after 24 hours. Diarrhea continues to be an issue. Nausea continues through the entire period; however, the current nausea could be contributed to the lack of food over the last 2 days as well as dehydration. Aching joints also continue to be a problem mostly in the lower back area.   Treatment was bed rest for 48 hours as well as 1000mg of acetaminophen every 6 hours. Gatorade/Powerade was drank as could be tolerated.
Patient fainted about 5 minutes post vaccine. We had them lay down for a moment and gave them water. Patient waited for 40 minutes after vaccine and recovered.
several pts recvd DTP from two vials (same lot); all pts exp inject site react which included swelling & discoloration of the skin (blueness);
For both injections, within 9 hours I developed a fever.   After the first shot, my fever peaked at 101.4 and I had a fever during most of the following day around 99 degrees..  For the second shot it went up to 102.5, lasting throughout the night.  After the second shot and during the fever period I was extremely dizzy as well with a bad headache that was not relived with aspirin..   The fever broke somewhere around 9 a.m. the following day and I felt very tired and had a bad headache for most of the day.
Atypical chest pain, elevated troponin, suspected myocarditis. Inpatient observation for 24 hours; serial troponins, EKG, Echo, pain control (toradol/Naprosyn).
Headache, nausea, chills, muscles that feel they need to be stretched.  Loss of appetite but no vomiting.. Signs started 12 hours post vaccine.
Contracted the COVID virus after being fully vaccinated. Positive test results on 08/27/2021. I had to get an infusion 09/01/2021.
Information has been received from an RN concerning a 38 year old female with a history of mumps as a child who on 4/15/91 and 9/24/97 was vaccinated with MMRII. On 10/19/99, the pt had a mumps titer drawn which was "equivocal". Subsequently, a "recent" mumps titer was negative. Additional info has been requested.
About 2-3 weeks post immunization, toes of both feet became swollen, purple, burning and painful to touch...within one week all symptoms abated...skin on toes is peeling off slowly and painlessly...after about two weeks, toes will be completely healed.  Identical symptoms after first dose...2.4.2021...Telemed visit with physician...suspected post-immunization immune response...little was known about patient immune-response to vaccine...since problem was already abating, and Covid numbers were high, I did not request an office visit for an official diagnosis. There was no reaction after doses 2 & 3. Thank you.
PAINS ALL OVER BODY; SHAKING; FEELING HOT; CHILLS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) 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 12-APR-2021, the subject experienced pains all over body. On 12-APR-2021, the subject experienced shaking. On 12-APR-2021, the subject experienced feeling hot. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, tiredness, pains all over body, chills, shaking and feeling hot was not reported. This report was non-serious.
8 weeks since first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 weeks since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 weeks since first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 weeks since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.
fever of 100.5, controlled with Tylenol  headache lasting 2 days, little relief with Tylenol or Advil
pain / pain at the injection site / area was still tender; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles this year).   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient had pain at the injection site from the first shot, like someone had punched her and the area was still tender three weeks later but had since resolved. The reporter consent to follow up. For tolerance of vaccine 2nd dose, refer case US2019188921.