chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 40 years 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's relevant medical history included: "Nasal allergies" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Negative; (19Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient was treated with Paxlovid from 09Oct2023 to 14Oct2023. The patient's symptoms seemed to improve and on 16Oct2023 she tested negative. She thought she was done with COVID-19 but then on 19Oct2023 she woke up sounding much more congested and coughing more and when she tested herself there was a faint positive line.
Blurry vision, dizziness, given water and juice. BP/pulse: 102/63, 73; 97/63, 73. O2 sat 100%. 90 minutes later, feeling better and discharged to home.
A few hours later post first vax, on 04/18, this female pt experienced fever, chills, joint pain, headache, flu-like symptoms.
This spontaneous report was received from a pharmacist and refers to an adult male patient. The patient may have been vaccinated with M-M-R II during childhood. On 31-JUL-2017, the patient was vaccinated with a dose of M-M-R II injection (dose, route of administration, lot number and expiration date were not reported). The dose of vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). On an unknown date in 2017 the patient had "a low titer". The outcome of the event was unknown at the time of the report. The relatedness between the low titer and M-M-R II was not reported.
Fatigue, excessive chills/shivering, headache, all over muscle/body aches and fever of 101.8
Patient came in for 6 month shots and received pentacel and variax together = to double doses of tdap ipv and him
Patient had peripheral vision problems and some anxiety.  The worst side effect is the severe migraine headache she has had for 8 days and counting since she got the vaccine.  She has a history of migraines but this one was untreatable and extended into her optic nerve.  It was also on both sides of her head rather than just one (which is how it normally is).  She went to the emergency room where they can usually treat it.  However, this time, their treatment did not work.  She said she also has a hard time finding words and is feeling more fearful when she rides her motorcycle.  She does not want to ride her motorcycle right now, due to these vision problems and anxiety.
This spontaneous report was received from a certified medical assistant refers to a male patient of unknown age. On 12-NOV-2012 the patient was vaccinated with PNEUMOVAX23 (lot # H016283 in verification process, expiration date 21-FEB-2014) intramuscularly. No concomitant medications were reported. Within 24 hours after the injection the patient developed extensive swelling of the arm that received the injection. No lab studies were performed. The patient was recovering from the event. The patient sought medical attention for the event by calling the physician. This is one of the two reports from the same source. Additional information has been requested.
Itching from head to toe - vomiting - fever - hot flashes - sweating - swelling - headache.
at site of Varivax, given on 9/17/07 1-2days later developed redness with blackhead with prudent drainage and pain skin abscess drained and cleansed with antibiotics ointment twice daily. Culture sent and placed on Bactrim DS x 10 days. Culture result
After the vaccine, we came home, and I gave her Tylenol. And then she cant sleep the whole night. She stayed tired and cant sleep the whole night, she fell asleep around 6-8. And in the morning, she has a headache. When I asked her how she feel she said she didn't feel ok, she had a headache. I gave her more Tylenol. I took them to the children er- we spent the whole night there, cause I wanted them to make sure they were ok. I wanted them to take blood work, but they wouldn't, they said it that they did not have a heart condition, so no blood work. We left er around 1 and I took them to have blood work, so we are still waiting. ER:
2 hours after shot, severe and fast angioedema in left hand and 4 hours later, mild angioedema in left foot. Swelling stabalized and appears to be going down  slowly - 6 hours after shot.
diarrhea/loose bowels; intestinal pain (cramping); intestinal gas; intestinal movement; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIARRHOEA (diarrhea/loose bowels), ABDOMINAL PAIN (intestinal pain (cramping)), CHRONIC GASTRITIS (intestinal gas) and GASTROINTESTINAL MOTILITY DISORDER (intestinal movement) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and Irritable bowel syndrome.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 25-Mar-2021, the patient experienced DIARRHOEA (diarrhea/loose bowels), ABDOMINAL PAIN (intestinal pain (cramping)), CHRONIC GASTRITIS (intestinal gas) and GASTROINTESTINAL MOTILITY DISORDER (intestinal movement). On 25-Mar-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 27-Mar-2021, ABDOMINAL PAIN (intestinal pain (cramping)) had resolved. At the time of the report, DIARRHOEA (diarrhea/loose bowels), CHRONIC GASTRITIS (intestinal gas) and GASTROINTESTINAL MOTILITY DISORDER (intestinal movement) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported        This case was linked to MOD-2021-061003 (Patient Link).
SA; Dose received: more than 3; Dose received: more than 3; This is a spontaneous report from a non-contactable other hcp (parent). A patient of unspecified age and gender received fourth dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported) intramuscularly, administered in right arm on 01Oct2021 12:15 as dose 4, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (Lot number not reported) intramuscularly at 12:30, administered in left arm; second dose (Lot number not reported) intramuscularly at 12:15, administered in right arm, and third dose (Lot number not reported) via an unspecified route of administered in right arm at 12:15, all on an unknown date for COVID-19 immunization. On an unspecified date, the patient experienced spondylitis ankylosing (SA) and dose received: more than 3. The outcome of event was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Ankylosing spondylitis, Extra dose administered, Off label use cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees, and investigators, as appropriate.
p/vax pt lt arm swelling @ site 9/24/99;swelling lt arm from shoulder to wrist;no redness, no fever 9/24/99-reduced swelling 9/25/99;no swelling able to use arm completely w/o complaint;
Low-grade fever; fatigue; headache/nausea; headache/nausea; sore arm; red mark about a half-dollar side; red mark about a half-dollar side with itching for 2 days post-2nd dose; This is a spontaneous report from a non-contactable consumer via sales representative. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. Patient medical history included obese, depression and anxiety. Concomitant medications included multiple unspecified herbal remedies for depression and anxiety. No prescription medication. She did not medicate when side effect occurred with either OTC pain relievers or any other alternative remedy. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation and no reaction on previous exposure to vaccine. The patient experienced several side effects with 2nd dose of BNT162B2. The patient experienced low-grade fever for 12 hours, fatigue, and headache/nausea. She also had sore arm and red mark about a half-dollar side with itching for 2 days post-2nd dose. The reporter stated no lingering remaining side effects. Outcome of the events was unknown. No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
delayed sleep; could not sleep in the whole night; Light discomfort in the arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep in the whole night), LIMB DISCOMFORT (Light discomfort in the arm) and DELAYED SLEEP PHASE (delayed sleep) in an 87-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hernia.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INSOMNIA (could not sleep in the whole night) and LIMB DISCOMFORT (Light discomfort in the arm). On an unknown date, the patient experienced DELAYED SLEEP PHASE (delayed sleep). At the time of the report, INSOMNIA (could not sleep in the whole night) and LIMB DISCOMFORT (Light discomfort in the arm) had not resolved and DELAYED SLEEP PHASE (delayed sleep) outcome was unknown.            patient have blood thinners.
had numbness in her arms and hands, and the right side of her face; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  numbness in her hands and arms, which is ongoing.  The numbness is also felt on the right side of her face (cheek) and only presents during exercise. When she walks long distances her legs become numb, as well.   The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Experiencing some allergies symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGIC RESPIRATORY SYMPTOM (Experiencing some allergies symptoms) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, 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 experienced ALLERGIC RESPIRATORY SYMPTOM (Experiencing some allergies symptoms). The patient was treated with FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) at an unspecified dose and frequency. At the time of the report, ALLERGIC RESPIRATORY SYMPTOM (Experiencing some allergies symptoms) outcome was unknown.            No concomitant product use was provided by the reporter.  The patient stated that don't feel very bad, but want to know if this could be season allergies.
second dose given 10 days early; This case was reported by a other health professional via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that had they had a client who walked in for the 2nd dose of Bexsero vaccine. After receiving a vaccine it was informed first dose was administered 20 days ago (so the second dose was given 10 days early),which led to drug dose administration interval too short. The reporter wanted to know was there anything that they should be aware of.
Pfizer-BioNTech COVID-19 Vaccine EUA. Approximately 30 minutes after shot, got a very bad taste in the mouth, then throat became numb and I could not swallow unless I really forced it.  I had to drink to be able to swallow.  Again had to really try before I could. Then roof of mouth, back of throat and back of tongue felt number as if I had novocaine.   The lack of swallow lasted about 10 minutes of forced swallowing.  The numbness continued for about 2 hours but I was able to do everything.  The numbness was more of an annoyance.
Imms given 3-4 and 3-6 patient developed a very red swollen upper arm with blistering. Arm was twice its size and red from elbow to shoulder. She was taken to Urgent Care, dx cellulitis, started on Keflex. Follow up with PCP 3-7-20. Redness and swelling improved. Blister unroofed and cultured: no Growth!
This spontaneous report was received from a registered nurse concerning an unspecified number of patients (age and gender not specified). The nurse stated an unspecified number of patients received improperly stored Rotavirus Vaccine. No adverse effects were reported. Additional information is not expected as the nurse declined to be contacted for follow-up.
arm soreness; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported; expiration number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness for about a day, but that was it. The outcome of the event was reported as unknown.  Information of lot number was requested. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021213475 Same reporter/ drug/ event for different patients
lump in the left arm; hot flashes almost immediately after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes almost immediately after receiving the vaccine) and VACCINATION SITE MASS (lump in the left arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced HOT FLUSH (hot flashes almost immediately after receiving the vaccine). On 20-May-2021, the patient experienced VACCINATION SITE MASS (lump in the left arm). On 12-May-2021, HOT FLUSH (hot flashes almost immediately after receiving the vaccine) had resolved. At the time of the report, VACCINATION SITE MASS (lump in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO CONCOMITANT MEDICATION WERE USED. NO TREATMENT DRUGS WERE GIVEN
This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse who was reporting for herself stated that the pharmacist who administered the SHINGRIX vaccine to her told her that he had 2 patients who had to go to the emergency room after receiving the vaccine. She stated they were not admitted and they did not die. This was all the information she provided. This case was linked to the case US2018071812 and US2018GSK075872, reported by the same reporter.
Patient complained of diarrhea and weakness starting the day after receiving vaccine. Patient is currently experiencing side effect, has not resolved yet. (08/10/2015 AM) Patient's husband also received same vaccine and is not complaining of any issues.
This spontaneous report was received from patient's daughter refers to an 88 year old father. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On 19-JUL-2017, reported as "1 week ago ", the patient, has had "joint pain in his hip, that he did not have", before getting the vaccine. The outcome of arthralgia was unknown.
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 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 69 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Lot number: FP7139) 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's relevant medical history included: "Parkinson's Disease" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: Oct2012; CARBIDOPA/LEVODOPA, start date: Oct2016; PRAMIPEXOLE, start date: Oct2014; RASAGILINE, start date: Oct2014. Past drug history included: Amantidine base, reaction(s): "Known allergies: Amantidine base". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes paxlovid.
Fatigue, drowsy; vertigo with nausea (very dizzy at rest, with position changes and when walking); on 09/08/2013 called personal physician and began taking Antivert 25 mg once a day; vertigo lessening on 09/09/2013; unable to leave home to symptoms from 09/06/2013 5:00 p.m. through 09/09/2013.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 12-OCT-2012 at 18:00, ZOSTAVAX lot # H012576 was exposed to -8 for an estimated total time out of range of 10 hours 20 min. On 01-NOV-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H012576, exp date 28-SEP-2013) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Injection site burned when administered; Felt dizzy and light headed; Heart raced and started sweating; Heart raced and started sweating; Throat felt swelled at base; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot Number: EN6204) as a single dose, via an unspecified route of administration in the left arm on 18Mar2021 at 09:00 for COVID-19 immunisation (at the age of 30 years old). The patient had no medical history. The patients concomitant medication included LOLOESTRIN for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced injection site burned when administered after 4minutes, dizzy and lightheaded, Heart raced and started sweating, throat felt swollen at base on 18Mar2021 at 09:00.  The patient was treated with BENADRYL for the event. At the time of report, the clinical outcome of the events injection site burned, dizziness, heart racing, sweating and throat swelling were recovered.   No follow-up attempts are needed. No further information is expected.
I administered both MMR and MMRV to the patient that was due for MMR and varicella.
Adverse event started approximately two hours after flu shot - weakness, fever, increased bp, trouble breathing, chills, headache.
Itching right thigh and complain of stomach ache, small redness rashes. Tx Benadryl 50 Mg @ 0950 Po. Observed for 1 hour. Discharge about 1120 back to clinic.
The patient was given a dose of the vaccine that was expired. The vial was from the previous day (6/24/21). No adverse events have been reported as of 6/26/21.
3 hrs later I had heaert palpitations and high blood pressure that is continuing 48hrs later and still unresolved.