chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild sore arm (after 1st dose); Patient received vaccine at the age of 14; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (mild sore arm (after 1st dose)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 54615) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included DEXMETHYLPHENIDATE HYDROCHLORIDE (FOCALIN XR ER) for ADHD, GUAIFENESIN and MELATONIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MYALGIA (mild sore arm (after 1st dose)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14). On 15-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received vaccine at the age of 14) had resolved. At the time of the report, MYALGIA (mild sore arm (after 1st dose)) outcome was unknown.        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 treatment medication details were reported.   This case was linked to MOD-2022-452812, MOD-2022-452102 (Patient Link).
For the first time in my adult life, I missed a whole period the month after the vaccine - the month of April.
Case number PHEH2014US024956, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 85-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
At 1353, client received two vaccines: Fluarix Quadrivalent lot # 9PG4D, and Pfizer first dose, lot # FP7137.  At approximately 1406 client reported "whistling in ears".   PHN asked client if it felt like a "ringing" sound or sensation, and client replied, "yes".  Client stated that he had no other symptoms, had never experienced a "ringing" or "whistling" in his ears, and that the sensation began when he stood up after being vaccinated.  PHN advised client to stay under observation for another 15 minutes and to follow up with PCP.  Client stated does not have PCP and stated desire to "step outside? and remove his mask.  PHN stated would give client a list of community clinics.  Client left the premises on foot and did not return.
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were also reported Psychiatric Medicines, Colic Acid. Treatment details was not reported by the reporter.
Painful rash; A Spontaneous report was received from a consumer, concerning her mother, a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced a painful rash.  The patient's medical history and concomitant medication were not reported.  On 11-Jan-2021, 15 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 25-Jan 2021, after the administration of vaccine, the patient experienced painful rash that seem to be moving from one arm to another. These rashes were of white patches, which seemed to be hot. Treatment information was not reported.  Action taken with the mRNA-1273 in response to the event was unknown.  The outcome of event painful rash was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Tinnitus  ear loss in left and right ear.  Constant humming in left ear 24/7
1st shot wasn't as bad as the second. Did have memory loss, confusion, bowel issues.  2nd dose amplified everything above. Depression got worse and worse. Bowels were swollen,  blood during bowel movement.  Felt faint about 15 minutes after 2nd injection.  Started to get dizzy. Drove home and had to rest for several days.  Got Itchy and my body swelled up as if I was having AL allergic reaction,  so I had an allergy test as well as another blood panel for everything else. I have no allergies. I have been unusually tired since 2nd dose, still have bowel issues and my mental health is fragile. Now I have to take Lexapro,  wellbutrin and Lamictal.
Patient experienced small pops of plaque on certain areas; Second booster made her arm hurt really bad; She felt horrible with muscle aches; Fatigue extreme; This spontaneous case was reported by a patient and describes the occurrence of SKIN PLAQUE (Patient experienced small pops of plaque on certain areas), VACCINATION SITE PAIN (Second booster made her arm hurt really bad), MYALGIA (She felt horrible with muscle aches) and FATIGUE (Fatigue extreme) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APREMILAST (OTEZLA) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (Patient experienced small pops of plaque on certain areas), VACCINATION SITE PAIN (Second booster made her arm hurt really bad), MYALGIA (She felt horrible with muscle aches) and FATIGUE (Fatigue extreme). At the time of the report, SKIN PLAQUE (Patient experienced small pops of plaque on certain areas) was resolving, VACCINATION SITE PAIN (Second booster made her arm hurt really bad) outcome was unknown and MYALGIA (She felt horrible with muscle aches) and FATIGUE (Fatigue extreme) had resolved.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of Small pops on plaque on certain areas was a reasonable possibility.   The reporter's causality for the events of Arm hurt really bad ,Felt horrible with muscle aches and Extreme fatigue was not provided.  To treat her skin plague patient used some topical cream .    Reporter did not allow further contact
31may90 pt vax 2nd hepta B. w/i few hrs pt ex wheezing and nausea. next day had flu like sx w/ chills, fever, abdo pain, and loss of appetite. seen in er sx remitted.
patients were administered improperly stored VARIVAX and PROQUAD; No adverse effects; This spontaneous report was received from a vaccine coordinator referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included sterile diluent..  On unknown dates, the patients were administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) not valid lot #S003127, lot #R030798 (verified to be a valid lot number), expiration date reported and established as 22-APR-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot #R023736 (verified to be a valid lot number), expiration date reported and established as 20-AUG-2020 (conflicting information also reported as "08/20/20200"). Both vaccines were used for prophylaxis, were reconstituted with a steril diluent which did not undergo a temperature excursion and were improperly stored at a temperature between 15°F to 46°F (22.8°F), during a time frame of 17 hours and 48 minutes. There was a previous temperature excursion reported at a temperature between 15°F to 46°F (32.4°F) for 34 hours and 45 minutes. The call was not because of a data logger.
Serum sickness. An infant received an injection of Prevnar. The infant developed a fever of 102F and was treated or serum sickness with Amoxicillin/potassium clavulanate. This is 1 of 5 pt from this facility who developed an adverse experience following receipt of Prevnar.
This spontaneous report was received from a pharmacist refers to a 70 year old female patient. The patient's concurrent conditions were not reported. The patient's drug reactions, allergies and concomitant medications were not reported. On 18-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, units and frequency not reported) (lot # N012127 and expiration date: 20-JAN-2019) on upper thigh, left lateral thigh muscle. It was reported that the patient had Flu shots (influenza virus vaccine inactivated (unspecified)) before, at the same time, on the opposite side. On 18-OCT-2017, patient had excruciating pain (pain), the patient could hardly walk (gait disturbance). It was reported that the patient took till that night to start feeling better, took a week just to sit down to use restroom. The outcome of the events excruciating pain was recovering and outcome of gait disturbance was unknown. The reporter did not provide the causal relationship for the events with suspect therapy PNEUMOVAX 23. This is one of the 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1710USA009526: US-009507513-1805USA007660:
This spontaneous report was received from a nurse regarding unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date, the patients were vaccinated with PROQUAD which was improperly stored. No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt c/o arm soreness that travels down the arm continuing for time following vaccine. Worsenes over time.
Patient is an employee at this store.  She passed out immediately after receiving injection.  She was unconscious for no more than 5 seconds then regained consciousness and remained in the vaccination room for 15 minutes.  She stated numerous times that she was ok and eventually went back to work on her own volition.
This spontaneous report was received from a doctor of pharmacy refers to patient of an unknown age who on 05-OCT-2012, was vaccinated subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 (lot # 669776/0614AA) that was expired. The vaccine expired on 27-SEP-2012. No adverse effects were reported. Additional information has been requested.
Pt woke up Saturday morning (1/30/16) at 7am and experiencing intense itching above the left elbow. Around 2pm, she noticed redness in the itching area. The area was hot to the touch. The itching radiated to her back. She experienced the symptoms until Monday evening (2/1/16) around 6pm. As of 2/4/16, injection area is slightly red.
received a third dose of Shingrix yesterday July 28, 2020; her legs were feeling weak; she was bloated.; This case was reported by a pharmacist via call center representative and described the occurrence of lower extremities weakness of in a elderly female patient who received Herpes zoster (Shingrix) (batch number NG5N7, expiry date 1st April 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th July 2018) and Shingrix (2nd dose received on 29th December 2018).   On 27th July 2020, the patient received the 3rd dose of Shingrix (intramuscular) and Boostrix. In July 2020, less than a week after receiving Shingrix and Boostrix, the patient experienced lower extremities weakness of and bloating. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the lower extremities weakness of, bloating and extra dose administered were unknown.   It was unknown if the reporter considered the lower extremities weakness of and bloating to be related to Shingrix and Boostrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 78 or 79 years old. The patient received 3rd dose of Shingrix vaccine, which led to an extra dose administered. The patient reported her legs were feeling weak and she was bloated. Pharmacist did not believe the bloating was related to the vaccinations. No further details provided at the time of the call.  The reporter consented to follow up.
Flu; Sickness; Psoriasis facial; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), ILLNESS (Sickness) and PSORIASIS (Psoriasis facial) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced INFLUENZA (Flu), ILLNESS (Sickness) and PSORIASIS (Psoriasis facial). At the time of the report, INFLUENZA (Flu), ILLNESS (Sickness) and PSORIASIS (Psoriasis facial) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
c/o of severe h/a, rt ear pain, N/V which began on 22OCT93; advised to see MD immediately; severe sinus & ear infect
Flushed/dizzy/warm 30-60 min following injection; Flushed/dizzy/warm 30-60 min following injection; Flushed/dizzy/warm 30-60 min following injection; Fever; Nausea; Malaise; Body aches; Joint pain; Headache; Chills; Painful left arm; This is a spontaneous report from a non-contactable nurse, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FJ1611), via an unspecified route of administration in the left arm on 22Nov2021 at 15:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriasis, irritable bowel syndrome, anxiety, depression, mononucleosis, reoccurring strep infection, COVID-19 and known allergies to egg and fin fish. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included eluxadoline (VIBERZI), risankizumab (SKYRIZI) and venlafaxine hydrochloride (EFFEXOR); all for unknown indication from unknown date and unknown if ongoing. On 22Nov2021 at 15:45, the patient was flushed/dizzy/warm 30-60 min following injection, experienced fever, nausea, malaise, body aches, joint pain, headache, chills and painful left arm. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flushed/dizzy/warm 30-60 min following injection, fever, nausea, malaise, body aches, joint pain, headache, chills and painful left arm was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
diarrhea; headache; nausea; sick body; This is a spontaneous report received via COVAES from a contactable consumer (patient). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 17Mar2021 12:30 (Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included fibromyalgia. Patient has no allergies to medications, food, or other products. The patient received medication(s) within 2 weeks of vaccination included letrozole (FEMARA). The patient was no pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced diarrhea, headache, nausea, sick body, all on 22Mar2021 12:00. Patient did not receive treatment for adverse events. The event outcome for all events was not recovered.  No follow-up attempts are possible.  No further information is expected.
Pt given HPV and Hep A vaccines. After vaccines given, pt wanted a pregnancy test and she was pregnant.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: Unknown) at the age of 74 years, in left arm for covid-19 immunisation, Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: Unknown), as dose 2, single (Batch/Lot number: Unknown) and as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Patients experienced a mild seizure during observation period following vaccine. EMS was called and patient came to immediately after. RN took vitals on Patient while we waited for EMS to arrive. Patient has history of seizure disorder but had no issue with 1st dose. EMS evaluated at scene and Patient returned to residence facility.
Flublok vaccine given to 3 year old child.  No adverse effects noted at this time.
9:10 am PREVNAR given, 9:25 she stated felt funny in the head, itch hands, feet with face and neck red, felt swollen. 10:33 am overall skin red blotchy, throat felt dry and right side throat felt like some thing in it. 11:02am returned to clinic. Blotchy red rash undersurface of arms bilaterally, chest abdomen and legs. No breathing diff. SOLUMEDROL given. Improvement noted in 20 mins. BENADRYL also as prescribed by provider.
Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injection site red the size of a quarter, hot and sore to the touch and hard. Arm aches into shoulder.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number XC534, expiry date unknown) and (batch number FY79G, expiry date unknown) for prophylaxis. Concomitant products included Pravastatin, Tamsulosin, ELIQUIS and TOPROL. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th April 2018, the 1st dose was an unknown dose. On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, joint pain and fatigue. On 14th April 2018, the outcome of the injection site pain and joint pain were recovered/resolved. On 15th April 2018, the outcome of the fatigue was recovered/resolved. It was not reported if the reporter considered the injection site pain, joint pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported 2 batch numbers 1 of adjuvant and other of lyophilized powder. The patient received SHINGRIX in left arm. The health care professional reported that the patient received SHINGRIX and developed pain at the injection site, fatigue and achy joints within 6 hours of vaccination. This case has been linked with case US2018116406, reported by the same reporter.
systemic ache-pain muscular (arms/legs); systemic ache-pain areas of articulation; weakness & fatigue @ x's severe; sleeplessness due to pain; onset 1st inject-cont swelling-joints; pain in joints & insomnia;
Patient presented to pharmacy a few hours after vaccine with swelling/redness  a few inches below the  vaccine site.  She took benadryl prior to arriving at pharmacy. Advised patient to call primary care provider.
itching and continue to get pain in arm and wakes me up at night if i have been laying on the left
itchy eyes, swollen throat, cough, violent and uncontrollable diarrhea and vomiting, spiked 103 fever, chills, massive headache. Lasted about 36 hours. Extreme dehydration followed.
After receiving the vaccine on Thursday I had a very metallic taste. Shortly after breakfast on the morning of the 25 I had a lump in my throat as though my food didn't go all the way down. Then, as the day wore on I got more & more fatigued; later in the day my lips were mildly numb. I had no appetite at supper time and started getting a headache along with chills. All day Saturday I had flu-like symptoms, chills (no fever) extreme tiredness and a dull headache and laid under a blanket all day, no energy. Saturday evening around dinner time I started feeling better and Sunday woke up feeling as though nothing had happened other than a dull headache and soreness at the injection site.
Dizziness & nausea (lasting 1day), pounding headaches(going on day 4), hardening of the injection site, soreness of the injection site, subdermal bruising (dark red/blue) about the size of a dime
18 min after injection. Throarlt began tonitch and feel tight, chest pressure. Light headed. Epi 0.3 given, sent to er, provided with solumedrol, benadryl, pepcid, ativan and 1750 cc of fluid. Released from hospital at 330.