chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient brought to the ED via EMS on 7/8/22 for shortness of breath and right-sided chest pain. At home, patient experiencing right-sided chest pain and increased shortness of breath. He increased his daily oxygen from 2L to 4L NC. COVID PCR test done in ED was positive. Patient admitted from 7/8 - 7/12 for acute hypoxic respiratory failure with combination of pneumonia and COPD, possible bacterial pneumonia, and COVID-19 pneumonia. Patient vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
Swelling to site, red, pain, fever, nausea, myalgia, chest pain.
Throbbing/Pulsating pain around area of injection site has increased over time since (guess at) date of adverse event onset.  No special reaction at time of injection.
Had fever of 102.3 deg F oral.  Took 1000 mg of acetaminophen and fever broke. No further fevers occurred. Also had muscle aches during fever.
Case number PHEH2015US026862, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 60-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 24 Oct 2015, which was out of temperature range (34 degrees). The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse event was reported following this administration error (incorrect storage of drug). Follow up report received form nurse on 26 Jan 2016: Updated reporters comments.
mild pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR139909   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shot of shingles vaccine in June so it was mild pain. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR139909.; Sender's Comments:  US-GSK-US2022AMR139909:same patient, other dose
My son received the DTaP/DTP/DT, the Hib and PCV vaccine on 7/14/2011 within the week or so he immediately started having diarrhea a case so bad it lasted several weeks the doctors had no idea what was causing it, the diarrhea subsided to turn into chronic ear infections that lasted from September until January and swollen lymph nodes that have never subsided in his neck and groin area. In February of 2012 he had tubes put in his ears to try to stop the ear infections and also was officially diagnosed with asthma he was wheezing and having problems breathing they checked him and he did not have pneumonia - he also has eczema.
Headache for 7 days intermittent requiring tylenol, ibuprofen 4 out of 7 days Dizziness transient on day 5 corrected with oral hydration Dizziness, presyncopal event, Sinus tachycardia, chills, nausea, headache at 930 AM on 12-22-2020. Sinus tachycardia lasted 12 hours and now improved. EKG twice, Holter and echocardiogram confirmed sinus tachycardia. Thyroid profile normal Normal comprehensive metabolic panel, CRP, ProBNP, ferritin levels are normal.
Injection site reaction, red, slightly swollen, painful circle approx. 3in in diameter after receiving influenza vaccination. Treated with antihistamine.
PINS AND NEEDLES TINGLING, NUMBNESS ON RIGHT ARM ON AND OFF CONSISTENLY. ALSO EXPERIENCING THIS ON LEFT HAND AND LEFT LEG.
Rash over my trunk that is spreading, the rash doesn't itch, it is not really raised, a few of the spots have white centers. They are on my chest, breasts, back and neck. Some seem to be in a line others are random
Lymph nodes still swollen to this day,; twitching of leg, upper lip; headaches after consumption of alchocol that were not bad at all prior to injection; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0172) via an unspecified route of administration in the left arm on 21Apr2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Apr2021, the patient experienced lymph nodes still swollen to this day, twitching of leg, upper lip and headaches after consumption of alcohol that were not bad at all prior to injection. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event lymph nodes still swollen to this day, twitching of leg, upper lip and headaches after consumption of alcohol that were not bad at all prior to injection were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected. .
Patient experienced headache, nausea, diarrhea, and was sick for 3 days.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 31-DEC-2021. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient's 16 year old daughter who did not vaccinated got COVID and patient got it from her. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, dose number is series 1, 1 total, start therapy date were not reported for prophylactic vaccination. The manufacturer was unspecified.  The reporter did not report any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose, dose number in series 2, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, two months after vaccination with covid-19 vaccine ad26.cov2.s booster dose, the patient experienced covid (coded as Confirmed COVID-19 Infection and Confirmed Clinical Vaccination Failure). The patient was so sick and mentioned that if she was not vaccinated, she would have ended up in the hospital. The patient took two home tests (coded as covid-19 virus test) and that showed positive. She did not blame the vaccine at all. She never went to the doctors (dose number in series 2). On an unspecified date, Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) which was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was associated with product quality complaint: 90000209631. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211265856-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a pharmacist concerning a 20 year old female patient who on 20-AUG-2007 at 11:30 AM was vaccinated IM into the left arm with a first dose of Gardasil lot # 656U50/0245U.  On 20-AUG-2007 the patient received her second and third dose of Gardasil and on 03-MAR-2008 she received her third dose of Gardisil (the lot numbers were not reported for the first and second injection).  The reporter reported that the patient experienced nausea and fainted after the first injection.  The pharmacist reported that the patient also experienced nausea and dizziness after her second dose of Gardasil.  She did not experience any adverse events after her third injection.  No further information was available.  The patient recovered on an unknown date.  Additional information has been requested. 2/16/2010 In follow up information the reporter reported that on 20-AUG-2008 after the first injection patient had a difficult time getting injections. SHe drove four hours to get to the doctor's office from her school and was tired and had not eaten anything. SHe got the injection and felt weak, nauseated, and then passed out for a few seconds. This happened outside of the office. SHe was instructed to eat before taking injection and the office made her stay little longer in the office after the other two injections. SHe did not have any other reactions after the vaccination. No further information was available. The patient recovered on the same day of vaccination of first dose. Additinal informational is not expected.
rash; headache; chills; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash), CHILLS (chills) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2023 at 12:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Oct-2023, the patient experienced CHILLS (chills). On 10-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEADACHE (headache). On an unknown date, the patient experienced RASH (rash). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. At the time of the report, RASH (rash), CHILLS (chills) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient reported that a rash had developed all over her breasts, chest area, armpits spine, there a large patch there under both armpits. This happened 48 hours after receiving the shot or might be it was already there before, and she did not realize until 11-Oct-2023. The first night she had chills.
Local Reaction- L thigh Swelling. DX cellulitis TX RX for Keflex 7-10 days follow up with PMD on 05/16/05.
Six hours after administration, patient (me) experienced onset of dental pain, specifically when any pressure was applied to tooth 12 from the lingual side outward.  This pain persisted unmodified through the next day, and was so severe I was unable to eat. However, at about 2PM the following day (Sunday), pain gradually remitted, and was gone by about 6PM.  As it happened, I had a dental appointment  the following day.  Dentist (contact info provided above) examined and reviewed recent x-rays.  There was neither dental nor gingival pathology, including decay or tooth instability.  Area was not tended on probing.  It appears most likely symptom was an  neuritis/neuralgia AE secondary to vaccination, albeit an unusual one.  Other vaccine-related AEs I experienced were typical, and mild-to-moderate -- muscular soreness at administration site that persisted about 5d, and mild malaise and fatigue for about 24h.
Washed out, just relaxed slight fever, and chills, muscle aches, joint pains, 1 Tylenol and went to bed
I got a Rash /large welt in the area. I got hive in the area and itchiness
A report was received from a health care professional on 11 November 2003, concerning an unspecified number of vaccinees who inadvertently received 1 ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1 ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 4 December 2003. An update report was received from a health care professional concerning a 94 year old female vaccinee who inadvertently received 1 ml of Fluvirin subcutaneously on 31 October 2003. No adverse symptoms were exhibited at the time of reporting. Follow up pending. Cross reference with: PJP200301345, PJP200301332, PJP200301333, PJP200301334, PJP200301335, PJP200301336, PJP200301337, PJP200301338, PJP200301339, PJP200301340, PJP200301341, PJP200301342, PJP200301343, and PJP200301344.
I took the  booster and had a fever for almost 2 days and developed thrush or some kind of infection resembling thrush in my mouth.
PATIENT COMPLAINED OF NAUSEA, SHORTNESS OF BREATH & HEADACHE, CHEST TIGHTNESS.  BECAME DIAPHORETIC ALL WITHIN MINUTES OF GETTING TETANUS BOOSTER.  PATIENT INSTRUCTED TO SIT ON FLOOR. ADMINISTERED EPINEPHRINE (1:1000, 0.3 ML sq) AND BENADRYL 50 MG IM.  BLOOD PRESSURE THEN INCREASED FROM 72/64 AT 0915 TO 82/52 AT 0931.  AMBULANCE TRANSPORTED PATIENT TO THE ER.  AT 1000, SPOKE WITH THE ER PHYSICIAN WHO STATED PATIENT WAS DOING WELL.
My left leg felt very stiff. It was kind of like a Charlie Horse feeling. I tried to stretch it out. That night as I was going to bed I was having shortness of breath. I thought it was due to me being outside doing yard work because they sprayed something on the rose bushes. The next day when I woke up, my leg was extremely stiff I couldn't move. I decided to go for a walk to try and stretch it out. I could barely catch my breath. I was very winded. I am usually able to do 3 mile walks every day. It was on a flat surface so it was weird. When I got home I was walking around the house and had trouble breathing so I went to urgent care. They thought it was blood clots in my lungs. After tests it was discovered that there were numerous blood clots. They admitted me for 3 days and put me on a Heparin drip and prescribed me blood thinners. After I was discharged I was better. I also had chest pressure during that time and 3 weeks after being discharged from the hospital the chest pressure came back so I went  back. They ran test but didn't find anything so they sent me home. I stopped taking the blood thinners as of March 1st. This was all very weird. I don't know if it was the estrogen hormone medication, my allergies, or the shot.
On the morning of 10-4-2013 reported headache, temperature of 101.0, nosebleeds with sneezing, puffy lips and face, watery eyes, stuffy nose.
This spontaneous report received from a nurse referred to a unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that an unspecified number of improperly stored doses of ROTATEQ (lot number: M026315; expiry date: 26-JAN-2018, lot number: M016238; expiry date: 07-DEC-2017, lot number: M006111; expiry date: 18-NOV-2017, lot number: M025565; expiry date: 06-NOV-2017, lot number: M019707; expiry date: 25-OCT-2017, lot number: M019706; expiry date: 24-OCT-2017) was administered to an unspecified number of unspecified patients. The vaccines were stored at 32 F for 13 cumulative hours. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001393:
Headache, resolved with Advil Redness, swelling, pain below Injection site Fatigue
Tested positive for COVID-2020; Taste loss; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-2020), AGEUSIA (Taste loss) and MALAISE (Not feeling well) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-2020), AGEUSIA (Taste loss) and MALAISE (Not feeling well). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-2020) outcome was unknown and AGEUSIA (Taste loss) and MALAISE (Not feeling well) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive for COVID-2020.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medications were not reported.  MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event of not feeling well, tested positive for COVID-2020 and taste loss was not provided.  Treatment information was not provided.  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.
Patient came into the clinic requesting the Pfizer Covid-19 vaccine. She stated that she received a Janssen Covid-19 vaccine 4/09/21 and was worried about the Delta variant. She stated that she and her PCP had discussed it and agreed that she should get the Pfizer Covid-19 vaccine. She received the vaccine 7/21/21
Second dose was unknowingly given 2 weeks apart, not 4. Patient has tolerated well, waited 15 minutes in clinic with no issues
After obtaining informed consent, Pfizer COVID booster 5 to 11 yr was given by CMA.  Pfizer COVID Booster IM Right Deltoid  Patient tolerated vaccine well at first then patient passed out. Father placed patient on table and I called for RN in Pediatrics to come in and assess patient.   CMA August 4, 2022 2:44 PM  RN called to room as patient passed out after receiving Pfizer COVID booster.    Patient awake and alert, lying on exam table with feet elevated. Dad fanning her with hat. She was able to verbalize her name, that her vision was normal and that she was not in any pain.    Obtained ice pack to place on her forehead, initiated vital sign assessment and requested in house pediatrician be notified to come assess patient.   Initial vital signs BP 70s/40s, HR 40s (adult attachment), SpO2 100%. Pediatric provider arrived to assess patient. Repeat vital signs BP 80s/50s, HR 50s (pediatric attachment), SpO2 100%. Patient stable per provider, ok to continue to monitor and discharge as appropriate.    Per parent this has happened before with shots. Patients PCP has recommended they pre-treat with Benadryl due to patient anxiety around shots and they did give her a dose before today's appointment.    Continuous pulse ox and heart rate left on patient to monitor. SpO2 continued steady at 100% and HR eventually came up into 70s/80s. Able to transition patient to sitting with legs elevated then to sitting with legs dangling. She tolerated well and was able to sip on ice water.    Around 1505 patient able to transition to standing without dizziness and ambulated independently. Discharged without assistance. In house pediatric provider updated.   8/5/2022 Called mom to follow up on patient status. She states patient did well overnight, no complaints other than some arm soreness. She is going great this morning as well.
Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 07-AUG-2019, the patient received a first dose of Hepatitis A Vaccine, Inactivated (VAQTA), intramuscularly, (lot # and expiration date were not provided) for prophylaxis.  On 25-JUN-2020, the patient received another dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Yes; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA003650: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA002536: US-009507513-2007USA003005: US-009507513-2007USA002514:
dizzy; fatigued; nauseous; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FATIGUE (fatigued) and NAUSEA (nauseous) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), FATIGUE (fatigued) and NAUSEA (nauseous). At the time of the report, DIZZINESS (dizzy), FATIGUE (fatigued) and NAUSEA (nauseous) 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.  Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Information has been received from a physician concerning a female with a history of chronic myeloid leukaemia who on an unspecified date was vaccinated with ZOSTAVAX (Merck). Subsequently the patient experienced a zoster rash at injection site after administration. At the time of the report the outcome was not reported. Additional information has been requested.
About a week after the first dose, she went to sleep. She woke up to a burning sensation in her left arm in the forearm. It was more painful towards the wrist, but went up to the elbow. She could not go back to sleep. Woke up boyfriend to take her to urgent care. They drew blood, gave her pregnancy test. Gave her an inflammatory (Toradol). Gave her a prescription to take at home. Then sent her home. She had to miss 2 days of work. After 24 Hours pain dissolved and has not returned.