chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; was diagnosed with Shingles by her HCP; had a rash throughout her back, shoulder, hairline and stomach; experienced "terrible back pain".; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. In February 2021, between 1 and 3 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and low back pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not recovered/not resolved and the outcome of the low back pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and low back pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and experienced fatigue and muscle aches, refer linked case. After receiving 2nd dose, in February 2021, she experienced "terrible back pain". Then she discovered she had a rash throughout her back, shoulder, hairline and stomach. She was diagnosed with Shingles by her healthcare professional. She had been taking Valtrex and felt better. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were not provided. The reporter did not consent to follow up.
I did received 2nd vaccination - No change in pain; This is a spontaneous report from a contactable Nurse (reported herself). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ELQ14Q), intramuscular, administered in deltoid right on 21Jan2021 14:00 (age at vaccination was 36-year-old) as dose 2, single for covid-19 immunisation in hospital. The vaccine was not administered at military facility. Medical history included covid-19 (Pertinent Details: Very minor symptoms well resolved prior to vaccine) from 12Oct2020 to 22Dec2020. The patient's concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ELQ14Q), intramuscular, administered in arm right on 30Dec2020 14:00 (age at vaccination was 36-year-old) as dose 1, single for covid-19 immunisation and experienced severe back pain. The patient stated that "i did received 2nd vaccination - no change in pain" on an unspecified date. The outcome of the event was not resolved. The reporter consider the Pfizer product had a causal effect to the adverse event.  Follow-up attempts completed. No further information expected.
2/9/2021 Almost instantly again, started to experience dizziness. Followed by nausea. I was extremely fatigued. The joint pain, hip, came when I got home; R hip; felt like I almost broke my hip. Lasted for at least a month.  Diarrhea started same day and lasted for 3 weeks. Into the first night, entire bottom half of bottom was all hot to the touch; only bottom half. Top half was cold. So much heat was coming off my body; sweating, uncomfortable.  3/2021 Ringing in ears. My ears, I woke up and couldn't hear; roaring. I couldn't hear at work. Went to Urgent Care; steroid shot. 60% hearing loss. Went to ENT. Stated that this has been happening with COVID patients. But I never had COVID.  He extended the steroids and weaned them down. Told I will have rest of my life; Meniere disease.  Due for follow up.
pt states he broke out in hives all over 12/26; he states nothing else could be causing it as he started no new meds and had no other vaccinations recently
received the first dose of Shingrix on 10/3/2019 and that she developed an outbreak of Shingles on 12/31/2019.; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On 31st December 2019, 89 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and developed an outbreak of Shingles on 31st December 2019. The patient did not receive 2nd dose at the time of reporting. The reporter consented to follow up.
dizziness; body aches; weakness; fast heart rate; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), PAIN (body aches), ASTHENIA (weakness), HEART RATE INCREASED (fast heart rate) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Heart rate: 55. On 09-Mar-2021, Heart rate: 82 and 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment medication included Tylenol
outside of right nostril swelling at tip; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of BNT162B2 (solution for injection) via an unspecified route of administration on an unspecified date (at the age of 63) at single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date it was reported that outside of right nostril swelling at tip 11 hours after second injection. Prior to vaccination patient was not diagnosed with COVID-19. The patient has been not tested for COVID-19 since the vaccination. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Patient presented with shingles on 9/18/20 at medical office.; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix. On 18th September 2020, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient was presented with shingles.
About a month after getting my first dose of the Pfizer vaccine, I began my period (menstruation) for the first time since May2021; This is a spontaneous report from a non-contactable consumer (patient).  A 54-year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at 100:00 at single dose in left arm for COVID-19 immunisation at the age of 54-year-old. Lot number was EW0158. Medical history included menopause in May2020. The patient was not pregnant at the time of vaccination. The patient never had period during the past year. About a month after getting her first dose of the suspect vaccine (13May2021), she began her period (menstruation) for the first time since May2020. The period lasted a week. The patient was not treated for the event. The patient recovered from the event in May2021. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
MACULOPAULAR RASH, HIVES DEVELOPED WITHIN 6 HOURS OF Td BOOSTER.
Dizziness, Headache, Myalgia, Arthralgia, Fever,  chills malaise Narrative:  Other Relevant History:
First symptoms started on: 10/13/2023.  Noted rash first on trunk.  Has been spreading to arms, neck and upper legs.  Not bothering him.  Had a low grade temp the night before the rash. Over the last few weeks he had been on Augmentin for a dog bite, which just finished a few days before this began.  Had MMR on 9/26.  No other new exposures.  Raised papular rash on trunk, back, arms and legs.  Polymorphous, some are more raised than others.
PATIENT COMPLIANS OF HEADACHE AND EXCESSIVE SWELLING AT THE IMMUNES SIGHT.
Shortly after receiving my second dose of Moderna I began having intense tooth pain (dentist has confirmed there is nothing wrong with the tooth) and high pitched intermittent ringing in both my ears.
Dizziness c/o feeling warm and dizzy w/ diaphoretic skin. Recovered after cold pack to neck and monitoring for 30 min. Narrative:  7 min after vaccine, c/o feeling warm and dizzy. Skin diaphoretic and pale. unlabored breathing. @1308: 98/54, 76, 96% O2 sat.; @1316: 122/66, 92, 20, 95% O2sat and stated feeling better. Observed for 30 minutes and d/c'd in stable condition. ambulated around the room and denied any c/o prior to D/C. Resolved.
This non-valid spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX with lot # R017944, expiration date 24-JUN-2020, lot# N026073, expiration date 20-SEP-2019, lot# N023960, expiration date 01-SEP-2019 (dose and route of administration were not reported) or PROQUAD with lot# R017800, expiration date 19-DEC-2019 and lot# N035934, expiration date 16-JUN-2019 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent, lot# R022280, expiration date 06-OCT-2019. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 15 minutes and between 15 to 46 (also reported as 20) degrees Fahrenheit for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. The case is non-valid due to lack of the patients' identifiers. Follow up information was received from a nurse on 27-MAR-2019. The Nurse stated that she had spoken with management after calling in the data logger excursion. Management denied permission to provide patient identifiers and dates of vaccination for the patients that were vaccinated with the above products after being involved in a data logger excursion. No further information is available.
It was reported in a published article, that a 4 day old male pt's mother was vaccinated with a dose of MMR II in the postpartum period after his birth in May 1993. On his fourth day of life, the pt curled up in a ball and cried for 24 hrs. He suffered from severe constipation during his first year of life, and has had persistent diarrhea ever since. He was diagnosed with autism. The author noted that "vaccination can be frequently associated with early onset autism." It was also reported that "in spite of its limitations, this study suggests that an autism/vaccine connection may exist." Upon internal review, autism was considered to be an important medical event (OMIC). It was unknown if medical attention was sought.
a dose may have been given from a vial that had been opened for 17 hours & stored at room temperature; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (a dose may have been given from a vial that had been opened for 17 hours & stored at room temperature) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (a dose may have been given from a vial that had been opened for 17 hours & stored at room temperature). At the time of the report, PRODUCT ADMINISTRATION ERROR (a dose may have been given from a vial that had been opened for 17 hours & stored at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   Reporter did not allow further contact
11/05/2001-patient contacted PHN and explained that they were experiencing head and back ache. they were informed that these symptoms were not usual side effects and referred to Dr. 11/06/2001 Patient went to ER for N & V, headache, backache. they were given Zantac for stomach, Vicodin for pain 12/14/2001-patient discovered she is pregnant. She then notified Merck
Achiness in the body; Shivering an shaking uncontrollably; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness in the body) and CHILLS (Shivering an shaking uncontrollably) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced MYALGIA (Achiness in the body) and CHILLS (Shivering an shaking uncontrollably). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Achiness in the body) and CHILLS (Shivering an shaking uncontrollably) outcome was unknown.            Relevant concomitant product usage were not reported by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.
01/27/22 presents to ED for "nausea and vomiting". PMHx of "ESRD on HD (MWF), diastolic CHF (EF 55%), GERD, and HTN"
Patient had swelling from her shoulder to her elbow. Hot, red appearance spreading onto chest as well. Itching, low grade fever.
Intense chills about 10 hours after shot, leading to overnight fever with a high of 102.4 degrees. Headache and sore arm the day afterwards, minor fever persisted. Two days after, fever was gone, headache remained, and red spots appeared on the palms of my hands (not painful, disappeared after a day).
Heart beating wildly early morning of 4/10/2022. And then continuing all day including having to breathe through my mouth to get enough air, fever, chills, VERY tired, and could not do anything all day. Never had this reaction to any vaccine in my whole life, including the 3 other Covid shots I received.
Chest tightness centered on thoracic cavity; Dizziness; Mild headache; Raised, itchy Rash across left arm and torso; Itchiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), PRURITUS (Itchiness), DIZZINESS (Dizziness), RASH PRURITIC (Raised, itchy Rash across left arm and torso) and FATIGUE (Fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fish allergy (Allergy to Shellfish) and Anaphylaxis on 01-Jan-2005.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FATIGUE (Fatigue). On 04-Mar-2021, the patient experienced PRURITUS (Itchiness). On 05-Mar-2021, the patient experienced RASH PRURITIC (Raised, itchy Rash across left arm and torso). On 06-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), DIZZINESS (Dizziness) and HEADACHE (Mild headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 06-Mar-2021 for Rash, at a dose of 75 milligram benadryl and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Mar-2021 for Rash, at a dose of 50 mg. On 07-Mar-2021, RASH PRURITIC (Raised, itchy Rash across left arm and torso) had resolved. At the time of the report, CHEST DISCOMFORT (Chest tightness centered on thoracic cavity), PRURITUS (Itchiness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Mild headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: increased (High) Body temperature slightly increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    This case was linked to MOD-2021-080728, MOD-2021-080775, MOD-2021-080775 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant Follow up - Patient demographic details updated. Suspect product Batch number added. AE outcome updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had a fever of 101.8 degrees. I had really bad body aches. I felt like I was run over by a bus. The right arm was hot, red, itching, and the knot at injection site was very swollen like a golf ball size. I couldn't break the fever for 3 or 4 days with Tylenol. The redness spread down my arm a little bit. On 11/5/2021 I went to local urgent care. They told me I had a reaction from the vaccine. They prescribed me with azithromycin 250mg 1 tablet for 5 days and Claritin 10mg 1x day. I also took Tylenol for fever and pain. My arm still feel itchy, a little hot, and a little bit red, but my fever finally broke.
Case number PHEH2014US025128, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 62-year-old male 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 19 Nov 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 (incorrect storage of drug).
Lower extremity pain and generalized weakness.  Eventually diagnosed with Guillain-Barre Syndrome. Discharged to a rehabilitation facility 3/12/2010.
Patient arrived to the pharmacy 2 days after receiving the vaccine and presented a swollen red arm that was hot to the touch. Patient stated that this was observed the following day after the vaccine was given and it had increased in size since then. Patient was directed to their PCP in which an anti-biotic was given.
No adverse event; Patient got the wrong one; Patient administered 0.25mL, instead of 0.5mL; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient got the wrong one), ACCIDENTAL UNDERDOSE (Patient administered 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 63B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient got the wrong one) and ACCIDENTAL UNDERDOSE (Patient administered 0.25mL, instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient got the wrong one), ACCIDENTAL UNDERDOSE (Patient administered 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  The pharmacist was multitasking while he was getting the shot ready.  No treatment medications were reported.