chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report to VAERS provides the following narrative: A report from VAERS (Health Authority) concerns a 20 year old male. Patient's relevant history and concomitant disease were not reported. Patient received FLUMIST (intranasal) on 18-Sep-2009 and H1N1 (intranasal) on an unknown date. He experienced Guillain-Barre syndrome like symptoms. The outcome of the Guillain-Barre syndrome was unknown. The reporter considered the Guillain Barre syndrome to be serious by criteria of hospitalization and patient also required emergency room.
spontaneous bleeding from L hand pinky cuticle and from R thumb proximal  phalanx volar aspect
devel of body-wide fine rash, urticaria, facial edema & pruritus
Site of injection became swollen and red within 24 hours. Swelling, redness and tenderness increased over following 4 days resulting in a bruise covering 3/4 of upper arm from the deltoid toward the elbow. Treatment: Tylenol and ice.
reconstituted ActHIB with " a plain diluent", not the ActHIB provided diluent, no AE; Initial information received on 27-Mar-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 2 months old patient (gender not reported) who received a 0.5 ml first dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ138AAA, expiry date: 31-Jan-2021) on 27-Mar-2020 via an intramuscular route in the left thigh for prophylactic vaccination.   The patient's medical history, past medical treatment, past vaccination and family history were not provided.  It was an actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, the patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
L deltoid with 4" reddened area-swollen-warm to touch- mom has been giving Tylenol.
Muscle pain; Tiredness; Feeling unwell; Chills; Injection site pain; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 18Mar2021 12:00 (Lot number: EN6199) at the age of 45 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Injection site pain"; HEADACHE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Tiredness"; MALAISE (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Feeling unwell"; CHILLS (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 21Mar2021, outcome "not recovered", described as "Muscle pain". Additional information: The patient weighs 220-230 lbs. The patient did not receive prior vaccinations within 4 weeks. The patient had no fever, had no swelling in the injection site, no redness, and does not know about any swollen lymph nodes. When the patient starts to get chills, he covers up, but then he gets really hot. The events tiredness, headache, muscle pain, feeling unwell, and chills were reported to have worsened. The patient claims that the more active he tries to get, the worse he feels. The events did not result in an emergency room or physician office visit, but thinks about going.  No follow-up attempts are possible. No further information is expected.
Numbness on the hand; Fatigue; Headache; Soreness of the injection spot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the hand), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness of the injection spot) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness on the hand), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness of the injection spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, HYPOAESTHESIA (Numbness on the hand), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness of the injection spot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
PT HAS SORENESS IN HIS ADMINISTRATION ARM, AROUND INJECTION SITE. IT HAS BEEN A MONTH NOW, SO PT CAME TO DISCUSS THE LIKELIHOOD OF THIS. HE SAYS HE NOTICES EVERYDAY. HE DOES HAVE NEPHROPATHY AND HAS INJURED HIS ARM YEARS AGO. FEELS IT IS DUE TO THIS VACCINE.
p/vax pt serum varicella zoster virus antibody test revealed negative varicella virus antibody titers;
pt was feeling very tired the day of getting the vax.  Next day she went to work but later started feeling bad like she had the flu.  She developed a severe headache, fever and body aches and pains.  She went home and went to bed.  She woke up next day with a headache so she contacted her PCP.  She spoke with the nurse was advised to take ibuprofen.  Pt is taking the ibuprofen which seems to help but she is still having head pressure and her head is very sore to touch.  She is feeling extremely tired.
Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.            Concomitant medications were not provided. Treatment details were not provided.
Pt recvd 3 Engerix-B vax given 31AUG89, 16NOV89 & 21FEB90 following these titer was neg;
Shingles rash - Upper left shoulder - Treatment: Valacyclovir 1 gram tablet 3 times per day, 21 tablets.  Treatment not complete.  Rash still present,  rash not spreading.  Day of shot 6/15/2021 - slight tingling top of left hand, left foot, left side of face.  Resided after 8 hours. 6/17/2021 to current (6/26/2021) - sneezing 6/18/2021 to current (6/26/2021) - mild chest congestion, wet cough, nasal inflammation (basically means, can't breath through nose), sinus congestion and drainage.  Treatment: 10 mg Loratadine, over-the-counter cough and expectorant syrup, over-the-counter nasal spray.)
Noticed a light rash on chest. Second day, the rash expanded to neck and face. Took Claritin, monitoring the rash at this time. Have also been experiencing sore throat and headaches for several days. Not sure if these are symptoms.
4 1/2 x 5 inch x 4 inch area of erythema 1 x 1 1/2 inch area with 1 blister & small papules.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Slight tingling in the arm patient received the vaccine in. Patient waited 30 mins while I monitored. Once tingling subsided and she reported she was \"feeling fine\" she left.
After injection left upper arm hurt, became warm and swollen down to elbow by evening. Visit made to MD who prescribed Prednisone and Keflex.
Tested positive for Covid on 11/4 while conducting testing for all residents after two residents tested positive.  Patient claims he is just feeling tired.
Information has been received from a consumer concerning a 17 year old female with asthma and no allergies who in the mid-1990s was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Two weeks ago", on approximately 20-NOV-2007, the patient experienced headache and general fatigue. She had skin soreness on the left side of her face and left side of her trunk. Also her right calf had skin soreness. The patient's mother was calling the symptoms shingles. The patient had no lesions and had been treated with Advil for pain. At the time of the report the patient had not recovered. Additional information has been requested.
Jaundice; This spontaneous case was reported by an other health care professional and describes the occurrence of JAUNDICE (Jaundice) in a neonate male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced JAUNDICE (Jaundice). At the time of the report, JAUNDICE (Jaundice) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020512 (Parent-Child Link).   See case MOD-2021-020512 for details regarding the child case.
5 days after vaccine, right sided chest pain which is constant and worse when taking deep breath.  Sent to ED to r/o pulmonary embolism
Patient fainted approximately 3-5 minutes after receiving the the shot..During the vaccine patient showed no signs of an adverse reaction.  While walking away after the vaccine was administered patient fell onto the floor.  Patient a had two minor injuries to the face.  After being alerted, I rushed to the patient's side to assess the situation.  Upon assessment, patient a had two minor injuries to the face, he was breathing and talking with no issues.  I asked him if he was currently taking any  medications or had any medical conditions, to which he responded no.  I assisted him to his feet and supported his arms while he walked to our clinical services room.  While there, I cleaned his wounds with peroxide and gave him an ice pack for his forehead.  I then sat with him until he was stable and his mother came to pick him up.
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (medically significant), outcome "unknown", described as "Tinnitus". The reporter (sister) stated that the tinnitus was very serious.  The lot number for BNT162B2 was not provided and will be requested during follow up.
She woke in the middle of the night 5/3/21 with "extreme" pain in left calf. Her leg was very sensitive - even the bed sheets were painful to her left calf.  The next AM 5/3/21 - the pt applied bilateral compression hose,  wore them continuously with no decrease in pain. Pt states "I'm very stubborn and I probably should have called or seen someone, but I didn't". She was planning on flying and her friends started advising her not to travel in case she had a blood clot. The pain never subsided and she presented to ER on 5/11/21. The ER did a full work up.  They called in RX of Xarelto. Her pharmacy did not have it in stock on 5/11/21. Yesterday (5/12) Started Xarelto 15mg BID x 3 weeks; then on week 4 - will increase to 20mg once daily.
Information has been received from a 70 year old female consumer with a previous reaction to sulpha and penicillin (unspecified) who in approximately 2005 (also reported as about 4 years ago) was vaccinated with a single dose injection of PNEUMOVAX 23 (manufacturer unknown) (lot number not reported).  On 07-SEP-2009 (also reported as "recently") the patient started coughing really badly.  The patient went to ER where she was told that it looked like beginning of pneumonia.  The patient was prescribed antimicrobial (unspecified) and stated that she was fine.  She also mentioned that she had no fever and was feeling fine except for the cough.  On approximately 14-SEP-2009 (also reported as about a week later) the patient recovered.  No further information is available.
The  night of vaccination (Sat): Pain at right side hip bone difficulties falling in sleep The next day (Sun): Pain at right side hipbone when I bend to put on socks, sit down, get up, or walk. No pain while sitting in one position.  The night the next day (Sun): The pain subsided enough that I could fall asleep. Two days later (Mon): The pain reduced enough that I could put on socks with little difficulties. I could move normally with little or no pain.  It is getting better rather quickly.
Entire left bicep sore for 2 days (no redness, swelling or rash). 8 days after vaccination left bicep still experiencing surges of mild to moderate pain at injection site.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 22-JUL-2016, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had five temperature excursions: 64 hours, 1456 hours, 232 hours, 64 hours and 88 hours. The lowest recorded temperature was 3028 F (-1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
I have had fatigue, temperature fluctuations (chills and sweats), runny nose, more frequent cough. On third day sore throat started.
The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 30Jun2017, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers, received via a sales representative. A 16-year-old female patient received on 07Jun2017 TRUMENBA (lot S26962, NDC: 000021841) intramuscular, in right deltoid, at 0.5 ml single and MENACTRA (lot U5514AB) in left deltoid, at 0.5 ml, both for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 07Jun2017, within 30 minutes after vaccination, the patient experienced excruciating pain to right arm (rated 8/10), hurt to move arm, tender to touch, arm looked swollen, injection site was warm to touch and slightly red. The events did not require a treatment and resolved on an unknown date in Jun2017.
Patient reported to the pharmacy morning of 10-12-19 stating right arm hurting and swollen. It woke her up in the night.   The right arm between the shoulder and an inch above the  elbow was swollen and warm.  The inside of the arm was slightly red.   She reported no other symptoms other than soreness.  I advised the patient to take ibuprofen over the counter and apply cool compress or ice pack for short time. I told her this was a sometimes expected adverse reaction for many vaccines but it was a large area.  I advised her to seek medical attention if worsened in color, swelling, pain, developed fever or other symptoms.  I tried to contact the patient @5:30pm 10-12-19 to check in with now answer. ( left a message for her to contact me).  The patient returned my call @11am 10-13-19.
Arrived at MD's office on 9/1/17-with RASH, redness, cramping, swelling in left arm shortness of breath fever, Pain in left arm.
blood in stool; muslce pain; a lymph nodes on the left hand side of my neck; This is a spontaneous report from a contactable consumer.   A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on Apr2021 (vaccine taken at 13:00) (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 39 years) for covid-19 immunisation.  Medical history was none. There are no known allergies.   The patient did not have COVID prior to vaccination.   It is unknown if patient was Covid tested post vaccination.  The patient's concomitant medications were not reported.  The patient experienced blood in stool (medically significant) on 09Apr2021 01:00 with outcome of not recovered and muscle pain on 09Apr2021 01:00 with outcome of not recovered.  The patient noted "a lymph nodes on the left hand side of my neck" on 09Apr2021 01:00 with outcome of not recovered.  Therapeutic measures were taken as a result of blood in stool, muslce pain and "a lymph nodes on the left hand side of my neck".  The patient was seen in the physicians office.  Treatment included pain medication and antibiotics.  It was unknown if the patient had any other vaccines in four weeks besides COVID-19 vaccine.   Information about lot/batch number has been requested.
This spontaneous report was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB, lot # L030872 with expiry date 11-JUN-2018, lot# L035880 with expiry date 11-AUG-2018 and lot # L038501 with expiry date 16-AUG-2018, (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states a large 2 inch lump under at the injecction site which was pruritic.  Reported on 02/07/2015 by patient.
EXPIRED DOSE OF JANSSEN COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned an 80 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 17-AUG-2022) dose was not reported, administered on 03-OCT-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 80 years old. No concomitant medications were reported. On 03-OCT-2022, the patient experienced expired dose of janssen covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose of janssen covid-19 vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20221006123.
A report has been received from a pharmacist concerning female patient. No information regarding the concomitant disease and concomitant drug was provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal), unknown dose for unknown indication, started on 05-Oct-2014. It was reported that the patient had administered inadvertently all of the FLUMIST QUADRIVALENT dose in one nostril to two patients. FLUMIST QUADRIVALENT was discontinued on 05-Oct-2014. The outcome of the event of inadvertently administered all the FLUMIST QUADRIVALENT dose in one nostril to two patients is unknown. The report was considered to be non-serious. Corrected report 22-Oct-2014: The source of the case was corrected from Non-interventional/ Post-marketing study to Spontaneous and the company causality was removed from the case.
This spontaneous report as received from a healthcare worker (also reported as practice manager) refers to an approximately 12 year old patient of unknown gender. No medical history and concurrent conditions were reported. On 17-APR-2015 the patient was vaccinated with GARDASIL 9 (lot number K004204, expiry date 12-JAN-2017) (dose unknown). On 29-JUL-2015 the patient was vaccinated with GARDASIL 9 (lot number K004204, expiry date 12-JAN-2017) and on 09-NOV-2015 the patient was vaccinated with GARDASIL 9 (lot number L023230, expiry date 28-JUL-2017) (inappropriate schedule of drug administration). No adverse effects were reported. There was no product quality complaint reported. The action taken and outcome of the events was unknown. Additional information has been requested.
Fever over 105. Stayed at 103 for 2 days, then 101 for two days, followed by a rash all over her trunk.  ER visit and pediatrician visits with ibuprofen and Tylenol with cool baths.
Unfortunately we did use this beyond the use date of 10/9/21.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient This case concerns a 55-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-391718 (Patient Link).; Sender's Comments: This case concerns a 55-year-old patient, unknown gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Woke up on 12/18 with chills, fever of 102, and achy. Also, noticed red rash on back (from shoulders to waist), under both upper arms, and belly on 12/19 (but said it could've been there on 12/18). On 12/19, spread to around neck. Pruritic ("couldn't stand it") and used hydrocortisone.