chrisvoncsefalvay/vaers-outcomes huggingface dataset:
All minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week; legs were still very unstable; booster; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Sep2021 at 01:15 PM (Batch/Lot number was unknown) (at the age of 46 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included breast cancer IV and known allergy to sulfa. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included capecitabine; tucatinib (TUKYSA); dabigatran etexilate mesilate (PRADAXA); venlafaxine hydrochloride (EFFEXOR); montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. The patient was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 05Mar2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 45 years old) as dose 1, single; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Mar2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 45 years old) as dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Sep2021 at 01:15 PM, the patient was administered the third (booster) dose of BNT162B2. On 29Sep2021, the patient's all minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week. The patient was prescribed 3 days on a fentanyl patch and dexamethasone (DECADRON). During that time, the patient was basically bedridden. The patient was 46 years old and was now on a cane because her legs were still very unstable. Though more manageable, the patient continue to have joint pain in the areas mentioned above. The events were reported as serious (disability). The events resulted to emergency room and physician office visit. The outcome of events all minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week and legs were still very unstable was not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
High fever, chills, body aches, fatigue, high resting heart rate, metallic taste in my mouth, dizziness.
As time progressed, my symptoms seemed to get worse. At first it was just fatigue and sleeping up to 10 hours per night. Then I felt extremely warm and nauseous and my arm developed a large lump that was very sensitive and painful. I had interrupted sleep the second night somewhat, but the third night I was up almost all night. This is the fifth day and I feel more nauseous and fatigued than ever.
Skin around her eyes is tingling; Skin around her eyes is swelling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Skin around her eyes is tingling) and SKIN SWELLING (Skin around her eyes is swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Panic attacks.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PARAESTHESIA (Skin around her eyes is tingling) and SKIN SWELLING (Skin around her eyes is swelling). At the time of the report, PARAESTHESIA (Skin around her eyes is tingling) and SKIN SWELLING (Skin around her eyes is swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Janssen COVID-19 Vaccine EUA Headache (mild) starting at 1:45 pm 3/6/21, became moderate at 7:00 pm, lasting until ~11:30 pm Chills (severe) starting around 7:00 pm, lasting until 10 pm Palpitations starting around 9 pm, lasting until 11:45 pm Mild injection site pain starting 1:30 pm, still occuring (12:15 pm on 3/7/21)
Ear infections; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infections) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. In 2022, the patient experienced EAR INFECTION (Ear infections). At the time of the report, EAR INFECTION (Ear infections) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.       It was reported that patient was delivered without any congenital anomalies and achieved all the expected developmental milestones. Patient was not  hospitalized. No confirmed diagnosis of COVID-19 was reported. No new birth defects (congenital anomalies) been noted since the last study contact  Concomitant and Treatment medications were not reported.   This case was linked to MOD-2022-645983 (Patient Link).
Significantly swollen lymph nodes in arm pit of right arm. Started 24 hours after receiving booster shot.
Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Emesis; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported different events for 6 patients. This is the sixth of the six reports.  A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 at a single does in the left arm for COVID-19 immunization. Medical history included dementia from 10Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced arm soreness (soreness in the arm and shoulder), emesis and nausea on 01Jan2021. The patient received paracetamol (TYLENOL) for the soreness, nothing for the emesis and nausea. The events were all resolved on 01Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
Pt reproted rash or redness around the injeciton site and spreading down the arm.
July 28, 2010, 10:00 PM: A pain in the muscle where the shot was given. The pain persisted throughout the night and the patient was unable to sleep. Pain and loss of appetite continued for one week. When the pain went away, the patient felt a dizzy "floating" feeling and a lack of concentration. This feeling persisted for one week.  Between August 9 - 13, 2010, the patient felt much better.  On August 14, 2010, the pain in the left arm came back and this time the pain was felt throughout the arm and shoulder in random places at random times. Pain was also felt throughout the body, mostly in the legs, upper back and left arm (mainly the muscle where the shot was given). Some mild chest pain was also felt. Between August 23 - 28 the patient felt much better but noticed her heart rate would increase more then usual when excercising. For example the patient normally only experiences an increase to 165 BPM at most when running. During this time, the patient noticed her heart rate going up to 200 BPM.  On August 29 to the present 2010. The patient experiences the same "floating," Dizzy feeling.
Vaccine was inadvertently given to patient after it was not properly stored under the conditions recommended by manufacturer. No symptoms present. Dose will not count and will have to be repeated.
1 Hour after receiving vaccine patient had red blotch on right cheek (50 cent) piece in size, red blotch on left neck (25 cent) piece in size. 9:45 am P88. BP 110/70 RR 20, no itching, no tingling in throat. Given Benadryl 25mg 1 tab PO. 8/9/07 Father returned call, no further problems.
Varicella like rash in a right S1 dermatomal distribution starting 3 days after vaccine. Resolving as expected given the time frame.
On 8/18/09, day following vaccinations, redness, warmth, tenderness both anterior thighs today, 8/19/09, just right thigh has redness, warmth, tenderness, some swelling.
Received 2nd step vaccine at 12pm on 1/27. At 10:30pm the same day i experienced acute onset of fever and chills, along with a slight cough and moderate headache. Fever and chills lasted ~30 hours and were accompanied by profuse sweating and shivering at times. I did not seek treatment, but monitored my symptoms, hydrated, and treated with Tylenol. Symptoms seem to have resolved the morning of 1/29, but fever/chills remained through the previous night.
sore arm for a couple days chills overnight fatigue almost immediately lasting 36 hours headache almost immediately lasting 24 hours Swollen glands under left arm pit for 4 days
High fever, headache, abdominal pain, nausea, confusion, paleness, lethargy, exasperation of asthma
Headache & Nausea Vomiting Narrative: Day 1 approx 6-7 hours after dose 1 of vacc noted migraine, nausea, vomiting, tickle in throat after vomiting took OTC meds for migraine; day2 minor HA, no other symptoms from previous day, no meds taken; day 6 noted swollen/tender lymph nodes in R axilla and under R breast, swollen lymph nodes lasted until day 9, resolved without intervention.
Fever and chills for 18 hours, max temp 101.2.  Exhaustion
The 2nd day after getting the Pfizer covid 2nd shot, around 11:20 am. I felt like somewhere above stomach (maybe liver?) had an exploding pain,  in addition almost every vain/nerve connecting to the organ were in pain as well. I tried to shout to my husband's for help who was in another room. However, the pain gets even worse if I tried to move or say something. The pain lasted for a few minutes, and went away. The pain would came back every half an hour to an hour, and started migrating to other organs after a while. So my lung started to hurt, it hurts even more badly if I tried to breathe in air; so I had to stay very still. In the afternoon I felt the pain in my chest, and it was so painful that my whole back hurts (it's like the pain is penetrating through my body to my back). The last time I felt any pain was that night, about 11:00PM, before I went to bed. The pain did not  come back afterwards. I didn't seek medical attention because everytime the pain comes, it would go away in like 5 -10 mins. Did not take any medication to treat the symptoms either.
Got the vaccine and then got shingles?suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient got Shingles vaccine and then got shingles, but they were not as bad as could had been. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Three later I felt a rapid heartbeat. My resting heart rate was at 130 for about 4 hours. It continue about 3 weeks , each day it will happen about 10 times. Also gradually heart issues, is was not as bad as my rapid heart beat. I had a phone consultation with different doctor and he recommended an EKG and the result looked fine. I am still dealing with this issues but is not as often as it was.
Initial information received on 17-Jul-2018 regarding an unsolicited valid serious case issued from a literature article. Introduction: Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis post flu-vaccine is a rare entity. Whether it is because of lack recognition or underreporting is unclear. It is difficult to determine the at risk group for ANCA-vasculitis associated with flu vaccine. To our knowledge this is the 9th reported case of ANCA-vasculitis due to flu vaccine. This case involves a 75 years old female patient who experienced anti-neutrophilic cytoplasmic antibody (anca)-associated vasculitis, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Notes: CAT scan of the chest done five months prior to this presentation was essentially unremarkable. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a serious anti-neutrophilic cytoplasmic antibody (anca)-associated vasculitis (vasculitis) (antineutrophil cytoplasmic antibody positive) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious sudden onset fatigue (fatigue) three weeks following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious extreme dyspnea with minimal exertion (dyspnoea) three weeks following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. (Other relevant tests included CBC and renal function were both unremarkable. A CAT scan showed diffuse bilateral patchy consolidation with coalesced nodularity in the upper and mid lung fields. All respiratory cultures were negative. Vasculitis workup was positive for cytoplasmic-ANCA (c-ANCA)). Final diagnosis was anti-neutrophilic cytoplasmic antibody (ANCA)-associated vasculitis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for anti-neutrophilic cytoplasmic antibody (anca)-associated vasculitis, as Unknown for sudden onset fatigue, as Unknown for extreme dyspnea with minimal exertion and as Unknown for anti-neutrophilic cytoplasmic antibody (anca)-associated vasculitis.; Sender's Comments: This case involves a 75 years old female patient who experienced anti-neutrophilic cytoplasmic antibody (anca)-associated vasculitis, while she received vaccine INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. CAT scan showed diffuse bilateral patchy consolidation with coalesced nodularity in the upper and mid lung fields. Additional information including patient's medical history, medical condition at the time of vaccination, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on available information role of a vaccine cannot be assessed.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) 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.   No relevant concomitant medications reported. No treatment information was provided.
This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old patient of unspecified gender received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration on 09Nov2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient previously received the first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date and the second dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date; both as a single dose for COVID-19 immunisation. On 11Nov2021 at 07:00, after the booster shot, the patient experienced arm pain, tiredness, headache, muscle pain, fever and chills; which started 2 days after the vaccination. The patient was fine on 12Nov2021 (reported as Friday). On an unknown date in Nov2021, few days after, the patient came down with an upper respiratory cold. The patient started to feel better as of 24Nov2021 (reported as today). 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 been tested for COVID-19. On 21Nov2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events arm pain, tiredness, headache, muscle pain, fever and chills was resolved on 12Nov2021; while that of upper respiratory cold was resolving at the time of this report.
Heart racing, 20 to 30 BPM more than normal. Doctor mention possible POT syndrome
Left arm red, hot, swollen after 2 days.  Told to see private MD.  Mom stated some fever-did not measure
Broke out into hives on chest. Left side of face and eye started to swell.  Friend who is an RN immediately had me take 3 Benadryl.
Burning and pain at site, Burning of face, nausea, extreme fatigue resulved after 4 days
DIARRHEA; ACHYNESS; FATIGUE; JOINT STIFFNESS; INTENSIFYING LIGHTHEADEDNESS; ITCHINESS AT INJECTION SITE; MUSCLE STIFFENING; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced itchiness at injection site. On 11-APR-2021, the subject experienced muscle stiffening. On 11-APR-2021, the subject experienced muscle aches. On 11-APR-2021 21:00, the subject experienced joint stiffness. On 11-APR-2021 21:00, the subject experienced intensifying lightheadedness. On 17-APR-2021, the subject experienced diarrhea. On 17-APR-2021, the subject experienced achyness. On 17-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diarrhea, and achyness, and had not recovered from joint stiffness, muscle aches, fatigue, itchiness at injection site, muscle stiffening, and intensifying lightheadedness. This report was non-serious.
Pt received smallpox vaccination on 18 Jan 08. First seen at ER on 27 Jan 08 then again on 29 Jan.  Reported LUE pain and sweeling for days s/p small pox vaccination.  Initially had pruritic, erythematous, sparse rash but widely distributed acoss trunks and extremities with more concentrated at (L) deltoid. On 29 Jan with increased redness, pain and swelling for several days at vacc site. No fevers.  Pt reported FHx of Eczema.   P/E SKIN LUE: Necrotic plaque x 1 Cm diameter w/ surrounding erythema, heat , TTP and swelling approx 8 x 10 Cm, marked with purple pen. Also larger distrubution of slightly raised erythematous lesions, 1 Cm across trunk and concentrated around cellulitis of LUE. Pt reported additional identical lesions on her legs.  TREATMENT: On 27 Jan: Oral Benadryl 25mg and Prednisone 60mg in ER, then discharged on HC 1% Crm AAA BID prn.  On 29 Jan: Keflex 500mg po QID #40, Motrin 400mg QID PRN.
tingly lips/ tip of tongue felt tingly; sore left arm; tingly face on the left side; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA ORAL (tingly lips/ tip of tongue felt tingly), PARAESTHESIA (tingly face on the left side) and PAIN IN EXTREMITY (sore left arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer (1st primary series dose,Lot number: EN6208,  Intramuscular) on 22-Mar-2021, Pfizer (2nd primary series dose and Lot number: EW0153) on 12-Apr-2021; for Product used for unknown indication: Flu vaccine in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine, Pfizer and Pfizer. Concurrent medical conditions included Allergy, Overweight, Allergic reaction to antibiotics (Terramycin,) and Drug allergy (Codeine).   On 05-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 23-Jun-2021, the patient experienced PARAESTHESIA (tingly face on the left side). On 23-Jun-2022, the patient experienced PARAESTHESIA ORAL (tingly lips/ tip of tongue felt tingly) and PAIN IN EXTREMITY (sore left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 23-Jun-2022 at a dose of 25 milligram, Dry free liquid gel. On 23-Jun-2022, PARAESTHESIA ORAL (tingly lips/ tip of tongue felt tingly) and PARAESTHESIA (tingly face on the left side) had resolved. At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            Concomitant medications were not reported.  The batch number for 2nd booster was reported as 056M21 (last letter cut off on vaccination card).  It was unknown whether the patient  had been diagnosed with/ tested positive for COVID 19.   The patient reported 20 minutes after administration of the injection, patient experienced a tingly face on the left side, tingly lips and tip of tongue felt tingly. Patient reported  it was just like that patient experienced after the first Moderna dose. The patient reported had no trouble breathing and no rash had a sore left arm. The patient took 25 mg,Benadryl (dye free liquid gel) and reported the events resolved 45 minutes later. The Benadryl patient took as treatment was expired in November 2018.   This case was linked to MOD-2022-594691 (Patient Link).
Pt recv vax 4/30/98, 5/10/98 pt exp extensive rash of varicella, on 5/13/98 pt was seen by Dr. given med.Also OM;