chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This is a spontaneous report via a Pfizer-sponsored program, from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), via an unspecified route of administration on 24Mar2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. About 7 hours after receiving the first dose of the vaccine (24Mar2021), he experienced back ache, rash on the back and was diagnosed with shingles as it was confirmed today. He was prescribed acyclovir and wanted to know if that will affect the efficacy of this vaccine. He wanted to know if it was okay to take the second dose since this was the only side effect he experienced. Then clarified that by 6-7 hours later, he started to have symptoms like shingles. He had a dull ache in his back and noticed a rash when he took off his shirt. Thought it might be an allergic reaction but went to the Urgent Care today and he was diagnosed with shingles and prescribed an antiviral. He said he was not in a lot of pain. He was prescribed the antiviral just because a small percentage of people actually have prolonged pain from the shingles and they just want to prevent that. His major concern is that he got the first dose of the vaccine and he does not want this to impact the vaccine itself. His second question is whether he should take the second shot, which he thinks he should since it is just shingles. Clarified that he has not started his prescribed antiviral. The outcome of the event was unknown.
Information was received from an unspecified source regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) lot # J003536, expiration date 25-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination was unknown. Follow-up information was received. The VARIVAX (Merck) was exposed to unknown temperatures for 5 hours during interoffice transport. The patient was revaccinated on an unknown date. No symptoms were reported. Additional information is not expected.
after the vaccination i had chills, fever, nausea, diarrhoea, and a headache for the first two days three days after i started developing difficulty breathing with a lot of chest pain, pain at the back of my back, also pins and needles in my lower legs and feet
This spontaneous report was received from a healthcare worker who was referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with unspecified number of inappropriate stored doses of GARDASIL 9 which had a lot # of L019297 and an expiration date of 18-AUG-2017 (routes, concentrations, doses and anatomical places of vaccination were not reported). The doses of GARDASIL 9 were stored at 32.5 degrees F for 68 hours without previous excursion. No product quality complaint was involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2022 at 15:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 72 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
"Hives" rash and fever appeared within 1-2 hours after the vaccine was administered.  Notified physician's office.  Applied children's skin allergy relief cream to the rash.  Respiratory infection appeared within a week and progressed into an ear infection which is uncommon for my son.  Increased fatigue and dark circles under both eyes noted for 3-4 weeks after the vaccination.  My so also had a large red, hard, and painful area on his leg at the site of the vaccination for several days after the injection.
Pt recvd 3 doses of Engerix-B & it was determined that pt had no titer p/3rd dose;
Temperature of 102; elevated heart rate of 99  for 9 hours + around 6 pm until 3 am.   Took 1 Tylenol extra strength about midnight.  Finally went to bed about 3 am.
pt recvd flu vax & was 1 of 5 pts who devel influenza & died;
Rash all over described as erythematous, inflamed, and itchy. Spares palms of hands, soles of feet.
first dose of Shingrix in May of 2022, but never followed up to get the second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comments: The Healthcare professional (HCP) stated that she had a patient that never followed up to get the second dose. The HCP stated that, the patient would be getting the second dose as soon as possible. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. Note: details provided was corresponding to the 1st dose as the 2nd dose was not received yet.
Patient felt faint about 5 minutes after the vaccine. Patient was immediately laid on the floor and legs elevated. She felt fine after a few minutes. Patient has a history of feeling faint after vaccinations and blood drawns.
some of it leaked on their arm/Not able to know how much of the vaccine she received; injection site hurt a little/arm a little sore; pink zone at the injection site that is the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (some of it leaked on their arm/Not able to know how much of the vaccine she received), VACCINATION SITE PAIN (injection site hurt a little/arm a little sore) and VACCINATION SITE ERYTHEMA (pink zone at the injection site that is the size of a quarter) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).   On 25-Feb-2021 at 9:20 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ACCIDENTAL UNDERDOSE (some of it leaked on their arm/Not able to know how much of the vaccine she received), VACCINATION SITE PAIN (injection site hurt a little/arm a little sore) and VACCINATION SITE ERYTHEMA (pink zone at the injection site that is the size of a quarter). On 25-Feb-2021, ACCIDENTAL UNDERDOSE (some of it leaked on their arm/Not able to know how much of the vaccine she received) had resolved. At the time of the report, VACCINATION SITE PAIN (injection site hurt a little/arm a little sore) and VACCINATION SITE ERYTHEMA (pink zone at the injection site that is the size of a quarter) outcome was unknown.            This report refers to a case of accidental underdose for mRNA-1273, lot # 010A21A  with associated AEs vaccination site pain and vaccination site erythema.; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 010A21A  with associated AEs vaccination site pain and vaccination site erythema.
Patient is describing severe arm pain in vaccination arm when raising arms/moving. Does not experience pain when arms are by his side. It is not painful to touch and does not show any bruising/swelling at injection site. States he has felt this way since his shot. Has not improved in a week. Also states he bench presses every day but could only lift the bar post-vaccine compared to his usual > 200 lbs. It has been recommended to try Tylenol in conjunction with the prescribed celecoxib to see if that would help relieve some of the pain.  Patient refused those recommendations. In that case, recommended to have his doctor check it out to see if there is something else going on. Denies any other side effect, including blood clot signs/symptoms such as but not limited to: shortness of breath, chest pain, leg swelling, persistent abdominal pain, severe or persistent headaches or blurred vision, easy bruising or tiny blood spots under the skin beyond the site of the injection.
Facial cheeks get very red and dry looking. This happened after her first shots but I found excuses for it, but it happened again this time.
Febrile seizure 2 days after DTaP, IPV, Prevnar. Did test positive for influenza A.
Nurse reported pediatric patient received adult dose of VAQTA. See additional AE cases 02457006 and 02457034/no PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.     On 22-AUG-2023 the pediatric patient was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # W023489 and expiration date 27-DEC-2023 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product administered to patient of inappropriate age).
CHILD WAS FIT BEFORE ADMINISTERING THE VACCINATION ....INJECTION ADMINISTRED:  FLU SHOT + HEPATATIS A VACCINE                                    ADVERSE EVENTS: VOMITTING, DIARHEA , LOSS OF APPETITE, FEVER FOR PAST 2 DAYS.
1st dose headache, fatigue for 2 days, dramatic chills 12 hrs after shot, then minor sweats but no fever.  Aggravated my vertigo, was resolving with significant PT/Medical treatment until 2nd shot.  2nd dose made vertigo  even worse than first shot.  2nd dose made acid reflux and congestion worse.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL and VARIVAX. Information regarding dose, route and lot number was not provided. Concomitant therapies included MENACTRA and TDAP (manufacturer unknown). The nurse reported that the patient was very anxious when she was informed that she would be receiving four vaccines in a clinic visit on an unspecified date. When the patient received dose of GARDASIL, VARIVAX, MENACTRA, and TDAP, the patient became "dizzy and passed out." The patient recovered fully, and the nurse attributed the patient's adverse experience to her own state-of-mind at the time of receipt of the four vaccine doses. The nurse stated that "her reaction wasn't unusual." "Patient became dizzy and passed out" was determined medically significant upon internal review. Additional information has been requested.
Pain; Chills/Shivering; warm to touch at injection site area; Injection site rash; Redness at injection site; Swollen at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 2nd October 2021) and (batch number 9235B, expiry date 29th November 2021) for prophylaxis.   On 9th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 9th August 2019, less than a day after receiving Shingrix, the patient experienced chills. On 12th August 2019, the patient experienced pain. In August 2019, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site rash. On an unknown date, the outcome of the injection site erythema, injection site swelling, pain, injection site warmth and injection site rash were unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, chills, pain, injection site warmth and injection site rash to be related to Shingrix.  Additional information received were as follows: The pharmacist was called in to question to how to proceed and asked any information on how to get rid of this reaction. The healthcare professional stated that the patient experienced chills and shivering 1st night. Less than a week after receiving Shingrix, the patient experienced redness, swollen, rash warm to touch at injection site area. The healthcare professional stated that 3 days after receiving Shingrix, the patient appeared on the reporting date as rash was spreading rapidly and pain.  The adverse event was collected. The reporter consented to follow up.
Information has been received from a physician concerning a 13 year old male patient who on 21-MAY-1997 and 22-AUG-2000 was vaccinated with the first and the second dose of MMR II.  On 13-DEC-2009 the patient experienced mumps.  The patient had no fever.  The patient had headache and left jaw pain for one day.  The date diagnosed was 16-DEC-2009.  It was unknown if the patient had sought medical attention.  At the time of report the patient's status was unknown.  Follow-up information has been received from a physician concerning a 13 year old male patient who on 17-JAN-2010 experienced mumps.  The date diagnosed was 19-JAN-2010.  The patient had poor appetite and no other symptoms.  The parotitis was on the left side.  The lab diagnostic tests performed: on 19-JAN-2010 IgM was <1:10, IgG was 8.19 and serum amylase was 99.  Additional information has been requested.
Diagnosed with renal cell carcinoma in Feb '22. Needing a kidney removal.  Not having elevated liver enzymes.
Information has been received from a physician concerning a 6 year old male who on 27-FEB-2007 was vaccinated subcutaneously with a 0.5 mL of varicella virus vaccine live (Oka/Merck) (Lot# 656079/1306F). Concomitant therapy included Nasonex and Flonase. On 01-MAR-2007, the patient experienced bump about 2 inches, swollen and red hot raised to touch at the injection site. Medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. It was reported that the patient's twin brother experienced an adverse event following vaccination (WAES # 0704USA04534). Additional information has been requested.
Severe soreness about an inch below the injection site.  Then redness about the size of a lemon that spread around the arm down to the elbow over the next 2 days.
chills; fever; achy, sore; she thought she had covid; Injecton Site Pain; fatigue; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injecton Site Pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension and High Cholestreol. Concomitant products included blood pressure pills for Hypertension, Lipid Pills and water pills for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE PAIN (Injecton Site Pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), PAIN (achy, sore) and COVID-19 (she thought she had covid). On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, INJECTION SITE PAIN (Injecton Site Pain), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever), PAIN (achy, sore) and COVID-19 (she thought she had covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Mild lingering headache, fatigue on and off four days after 2nd shot.  Lasted for about 5-6 days
Rash over abdomen and chest bilateral. Rash resolved with steroid application after 7 day trx.
No adverse effects reported; the patient received her first dose of the GARDASIL 9 on an unspecified date in January 2019 and received the second dose on 09-OCT-2019; This spontaneous report was received from a pharmacist concerning to a female patient of unknown age.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unspecified day in January 2019, the patient received her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 09-OCT-2019, the patient received her second dose of  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
pt had a seizure that lasted 20 second the morning after receiving the second dose of her vaccine. No further symptoms or abnormalities noted after this event
swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is a spontaneous report from a contactable nurse, reporting for a patient.  A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  lot number: EJ1685, via intramuscular on 22Dec2020 at 14:45 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination.  Medical history included asthma, celiacs, and hypertension from an unknown date. The patient had known allergies to shellfish, latex, sulfa, Levaquin, Morphine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydrochlorothiazide, zyrtec, dicyclomine, ibuprofen, benadryl, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020, the patient experienced soreness to injection site for 2 days (23Dec2020 and 24Dec2020). On 26Dec2020 at 16:00, she started having chills and headache. On 27Dec2020 chills were to the point where she couldn't get warm. Shivering chills. She remained afebrile just bad chills for 2 days. On 28Dec2020, she noticed swollen supraclavicular lymph node to left clavicle area which  was painful to touch and approximately quarter in size. It was not as painful today and swelling was starting to subside. The patient did not receive treatment for the events. The clinical outcome of soreness to injection site for 2 days was recovered on 25Dec2020. The clinical outcome for headache, chills, and swollen supraclavicular lymph node was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Pulmonary embolism; Chest pain; Shortness of breath; Arm swelling; Soreness in her arm; Local reaction in the lymph nodes of the axilla; A spontaneous report was received from a physician concerning a female patient who  received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pulmonary embolism, arm swelling and soreness, shortness of breath, chest pain and a reaction in the lymph nodes of the axilla   The patient's medical history includes pulmonary embolisms. Relevant concomitant medications were not reported.   On an unknown date, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced a pulmonary embolism, arm swelling, arm soreness, a local reaction in the lymph nodes of the axilla, shortness of breath, and chest pain.  CT scan showed small acute embolism.    Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the events pulmonary embolism, arm swelling and soreness, shortness of breath, chest pain and a reaction in the lymph nodes of the axilla were not reported.; Reporter's Comments: Company Comment: This spontaneous report concerning a female patient who experienced unexpected serious event of pulmonary embolism and nonserious events of arm swelling and soreness, a reaction in the lymph nodes of the axilla, shortness of breath, and chest pain. The patient developed the events on an approximately 5 days after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Pulmonary embolism was confirmed via CT. There is not enough information to adequately evaluate and assess the event of pulmonary embolism.  Swelling and soreness, a reaction in the lymph nodes of the axilla are temporally associated with the vaccine administration and in the absence of any other etiology, a causal association between these events and the administration of mRNA-1273 vaccine cannot be excluded. main field defaults to possibly related' for all events.
Received Shingrix Vial in AM. 11/22/19. About 10 PM had shaking chills, so bad went right to bed.  Awoke at around 6 AM in ANOTHER room and ANOTHER bed. no idea how/when i got there.  Chills subsided, had no idea when or how i got into this other room.  Felt better by then.  Took temp at 8 AM - 101.  Everything normal  by next day.