chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was concerned that the vaccine did not work for her; This is a spontaneous report from contactable consumer reported via Medical information team. A female patient of unknown age received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) both via an unspecified route of administration on unknown date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that when she received her first dose of the BNT162B2, she was scheduled to receive her second dose 3 weeks later. However, she received an email that said that the vaccination site had run out of vaccines and her second dose was rescheduled for 4 weeks later instead, which she received yesterday. The patient stated that, she did not have any side effects after receiving both doses. She stated that she didn't even have a sore arm. The patient was concerned that the vaccine did not work for her because she did not have side effects. She wonders if it was because she was older and that's why she did not experienced any side effects. At the time of this report the event outcome was unknown.  Information about batch number has been requested.
10/11/16- pt received FLUZONE in right arm and PREVNAR 12 in left arm (site of reaction). Pt contacted MD pm of 10/13/16 complain of fever and mild puffiness of left side of face. Came to pharmacy 10/12/16 to ask about reaction. Red area around site of Admin revealed to be approximately 6"x5". Suggested ice packs and antihistamine. (Spoke to MD and she attributed to normal reaction to vaccine).
940 AM found patient on floor with fists lasted approx. 3-5 seconds after patient responsive but c/o headache, dizziness, nausea - BP 122/82 - skin cool and clammy - MD in to check patient c/o of same symptoms but with onset of vomiting - responsive at all times but drowsy  - transported to hospital 1030 AM. (when patient fell she hit her head on a cabinet).  05/29/2007 MR received for o/n hospitalization for subdural hematoma. Pt had a  vaso-vagal syncopal episode after receiving vax, which resulted in a fall where pt. hit head. (+) LOC and seizure.  PE: (+) for occipital tenderness. Not oriented to date. T4-L5 tenderness. Final DX: Head injury.  L Parietal-frontal SDH.
I had facial swelling, lips tongue, neck, face and I also had a tingling sensation. I reached out to my allergist; she diagnosed me with angioedema and internal urticaria and had me taking ZYRTEC once a day. After two weeks she had me stop taking the ZYRTEC and within seven hours my throat closed up and I had to be transported by ambulance to the hospital. I went into anaphylactic shock and treated me as per protocol. I was sent home and advised to take three medications to keep the swelling down. On the last breakthrough they put me on 4 ZYRTEC, 2 BENADRYL every 12 hours and 1 famotidine every 12 hours but I was nonfunctioning. I had a reassessment, and the allergist switched the ZYRTEC to allergy and took the me off the BENADRYL. I will be getting reassessed to see if I can eventually be weaned off these medications.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Cleocin), and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting and the patient stated that she was taking other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: unknown) dose was not reported, 1 in total was administered on 20-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 56 years old. Concomitant medications included ibuprofen/pseudoephedrine hydrochloride (Advil cold and sinus)  The patient additionally received non-company suspect vaccine Pfizer Biontech Covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and were not reported, batch number: FH80Z8 expiry: unknown) dose was not reported, administered on 29-NOV-2021 to left arm for covid-19 prophylaxis.  The patient received non-company suspect vaccine Pfizer Biontech Covid-19 vaccine (tozinameran) (dose number in series 3) ( form of admin, route of admin, and were not reported, batch number: 33025BD expiry: unknown) dose was not reported, administered on 09-JUN-2022 to left arm for covid-19 prophylaxis which was an revaccination with different covid-19 vaccine (dose number in series 3). On NOV-2022, the patient experienced COVID-19 (suspected covid-19 infection) (dose number in series 3). On 29-NOV-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 3-DEC-2022. The patient had reoccurrence of symptoms 3 days after symptoms ended. On 09-DEC-2022, six days after non company suspect drug paxlovid treatment (for covid) laboratory data included: COVID-19 rapid POC test Negative (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
she also had has similar side effects: Fever; she also had has similar side effects: diarrhea; she also had has similar side effects: arm pain; she also had has similar side effects: sluggish; she also had has similar side effects: sleepy; Her side effects were a lot more intense than the second vaccine dose 3 (booster); Her side effects were a lot more intense than the second vaccine dose 3 (booster); This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 84-year-old female patient (reporter's Mother) that:  An 84-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/lot number: Not provided, Expiry Date: Not Provided) via an unspecified route of administration on an unspecified date in 2021 as dose 3 (booster), single for COVID-19 immunization. Patient medical history included Horton's disease. The concomitant medications were not reported. Patient took BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1, single and received dose 2 of BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient experienced similar side effects: fever, diarrhea, arm pain, she was sluggish and sleepy on an unspecified date in 2021. The report was not related to a study or programme. Investigation assessment was not provided. Reporter stated that patient will be fine, but she noticed her side effects were a lot more intense than the second vaccine, at the same time it's probably going to work just fine, and she is not worried. Reporter states that she doesn't want her information being shared with 3rd parties, and she does not want it shared with other people on the internet. Reporter states that she had to remove herself from 82 different things for that she would stop being contacted. The clinical outcome of all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101312073 Same reporter/product, different patient, similar side effects
Inadvertently given the second dose at day 11; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently given the second dose at day 11) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently given the second dose at day 11). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently given the second dose at day 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. The patient received first dose of Moderna vaccine and then inadvertently given the second dose at day 11 so he did not had the 28 days window.
Erythematous rash, swelling, Induration at the site and proximally near elbow area
Round red painful site that continued to spread. Treatment: benedryl and prescription from urgent  care .. cephalexin 500 mg
Information has been received from a consumer concerning her 16 year old daughter with a history of "small septal defect" and no drug reactions/allergies who on 20-JUN-2008 was vaccinated intramuscularly in the right arm with first dose of GARDASIL vaccine (yeast) (lot # unspecified). Concomitant therapy included hormonal contraceptives (unspecified). It was reported that the patient fainted and fell off exam table seconds post vaccination. Upon further examination by physician, the patient was determined to have a concussion. Unspecified medical attention was sought. It was reported that the patient was getting worse and the physician will be scheduling CT scan if symptoms won't subside. At the time of this report the patient has not recovered from her experiences. No further information is available.
Patient got Janssen vaccine after usual intake evaluation. She neglected to say she is allergic to citrate (one component of the  vaccine) and realized it later while  carefully reading the  fact sheet while waiting 30 minutes.  Nurse vaccinator monitored her carefully after she c/o a scratchy throat but  was otherwise OK except an elevated pulse.  Patient took two benedryls she had brought with her. She was anxious and still with scratchy throat, but no respiratory problems.  She was encouraged to go to the ED but she did not want to go by EMS. Her husband was called and picked her up.  I called at 4:30pm and she was doing well after a trip to the ED where she was given steroids. She was instructed to return to the ED if she had any CP, dizziness, SOB, or palpatations.
Extreme lethargy after Hepatitis B vaccination that was administered at approximately 24 hours after delivery of child.  When performing metabolic tests afterward where heel was pierced to draw blood there was no reaction to the needle at all nor to the strong pressure that had to be put on his heel to extract the blood.  There was no motion of his body, limbs or facial muscles during this whole process.  For days following the vaccination he was lethargic with bouts of screaming fits.  His first 24 hours of life he was very responsive to even light touch.
Patient has a red warm area at injection site. Area measures 2 inch wide  and 1.5 inches long on 12/5/18. Mom was advised to monitor area closely. Use ice and Motrin for pain and discomfort. Return to office or call if this worsens.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 at 14:00 as dose 1, single (Lot number: ER8729), in right arm, on 01May2021 at 13:00 as dose 2, single (Lot number: EW0170), in right arm and on 04Nov2021 at 15:00 as dose 3 (booster), single (Lot number: FG3527) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 065k21a) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing), notes: known allergies penicillin. The patient's concomitant medications were not reported. The following information was reported :VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are needed. No further information is expected.
Patient wished to receive the bivalent booster vaccine from Pfizer for COVID.  Instead she was given the original Pfizer vaccine.  Patient was contacted and no adverse events, signs, or symptoms were reported.
4 hours after injection hives on arms torso, legs. called manufacturer and took Zyrtec and Benadryl . Today called Dr. and was advised to take Benadryl until hives go away. right they are not as raised  just looks like rash that itches.
There was not a adverse event patient was given a high dose Influenza vaccine and should of received a regular Influenza vaccine.
A report was received from a health care professional on 21Nov02 concerning a eleven vaccinees between the ages of 56 and 84 years who were inadvertently administered 1ml of Fluvirin on an unreported date. On an unreported date a eleven vaccinees were inadvertently administered 1ml of Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporter's causality assessment. Update 1 31Dec02: A follow up report was received from a health care professional indicating that a 78 year old male vaccinee was inadvertently administered 1.0ml of Fluvirin on 21Nov02. Cross reference with: PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200899, PJP200200898, PJP200200907.
hoarseness, cough, pruritus, treated with IV solumedrol and diphenhydramine
As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I couldn't lift my arms and once I closed my eyes, I could not muster the strength to open them.  I felt like I was going to faint and then I got nauseated and I knew I was going to throw up. With my husband's help, I did manage to get to the bathroom (about 6 steps away).  I threw up and immediately sat down in the nearest chair.  I threw up a second time into a vessel after that.  I then got a massive headache and chills.  I could barely walk with assistance up the stairs to go to bed.  I have never been more fatigued.  After going to bed, I slept all night and woke the next day still fatigued, but nothing like the night before.  I was able to work, even though I felt really tired.  I did not have much of an appetite all day and two days later, I still feel fatigued.
I fainted at the facility I was at 10 minutes after the shot. I've since had burning at the injection shot (daily,  months later) and a  pain in the left side of my breast. I am often dizzy with the ground feeling like it's moving. I fainted a second time after a dizzy spell a few weeks after the second shot/fainting episode. My heart is often racing post getting the vaccine.
Feeling sick for now 4 days, almost 96 hours after I got my vaccine. Can?t find one section on CDC where it says you?ll be having a bad cough for days; just says fever and it will last 1-2 days. You guys really don?t know shit do you?
pt rcvd vax; pt devel hives on arms & itchiness on upper arm;
The day after my shot I noticed a very large bruise about 6 inches below where I was injected. It continued to grow and get more painful. I was more concerned about the soreness in my left arm from the shot, so I didn't think much of the bruise until I realized that it is now 2 weeks and I'm still bruised and in pain. I've spoken to my pharmacist and they were VERY concerned that I hadn't reported this sooner. The bruising has begun to heal and turn the ugly "yellow-purple," but it's still quite sore.
urinating frequently at night; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:30 as dose 4 (booster), single (Lot number: GH9702) at the age of 38 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 3 (booster)), administration date: 10Jan2022, when the patient was 38-year-old, for COVID-19 Immunization, reaction: "frequent urination at night"; COVID-19 vaccine (Dose 1, Primary Immunization complete, Manufacturer unknown), for COVID-19 Immunization; COVID-19 vaccine (Dose 2, Primary Immunization complete, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: NOCTURIA (non-serious) with onset 14Sep2022, outcome "unknown", described as "urinating frequently at night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received bivalent booster on 14Sep2022 and soon after started again urinating frequently at night. The patient did not have COVID prior vaccination and did not test for COVID post vaccination. The patient did not receive other vaccine in four weeks. Facility type where vaccine was administered was at doctor's office/urgent care.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201166596 same reporter/patient/product/event, different dose;
From emergency report: Patient reports she woke up Saturday morning with a fever of 101 which was resolved with Ibuprofen.  Sunday morning she developed an intermittent headache.  At 12:50 am Monday, she had onset of shooting pain in her right arm and leg.  She later woke up with the same tingling and numbness in the right extremities.  Stayed constant throughout the day.  Pain in leg worse with walking.  Consistent headache not relieved by ibuprofen.  Was advised by doctor to go to the emergency room.
This case was reported by a nurse via call center representative and described the occurrence of unwell in a adult patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 6th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Nurse on the line reporting patients received their first SHINGRIX the day before reporting and got very ill. The reporter declined to provide patient details or any further information, would just like her question addressed.   No further information captured.
none to date; I ordered 2 month old vaccines for pt, and my medical assistant inadvertently gave pt the H1N1 influenza vaccine because her older sister was getting that vaccine that same day / time
Neurological symptoms- numbness hands and feet. Paralysis. Difficulty swallowing. Loss muscle tone both Upper and Lower extremities. Lost appetite and 100lbs. Parkinson/ALS/MS symptoms. Inability to walk. Inability to dress self. Inability to shower self. Dependent on  spouse. Thought was going to die. Then had a sub-occipital decompression with C1 laminectomy to correct Chiari Malformation which was triggered by Vaccine
Patient vomited and had fever that night. Went to doctor's office next day (Thursday) and had swelling/pain on arms and legs. Dr. recommended going to ER. At ER, patient was treated empirically with Vancomycin and Cipro. Patient was found to be septic. MRI and Ultrasound were negative. Treated with steroids and patient sent home Tuesday evening (10/30).
grandmother reports raised red wheal approximately the size of a half dollar on 10/13/22. Site is warm to touch. Area is being monitored. Using Benadryl and cold compress. If worsens she will seek evaluation by primary care.
Pt states that since the morning following the vaccine his arm, neck, shoulder & ear lobe have been hurting. He describes as shooting pain like a nerve.
Headache, Fever, REPORTED Tmax 103.2 ~9.5 hr after second vaccine adminisiterd Narrative:  REPORTED Tmax 103.2 ~9.5 hr after second vaccine adminisiterd
lower back pain bilaterally; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced lower back pain bilaterally on 28Dec2020.  She mentioned she didn't lift anything heavy or do anything since yesterday to cause the lower back pain. She clarified the pain started in her lower back and spread bilaterally. She asked if lower back pain is a common side effect of the COVID-19 Vaccine. She said she has never had lower back pain like that before. Event outcome was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Right ELBOW AND POSTERIOR FOREARM - RASH -MACULAR PAPULAR wAISTLINE- ITCHY only no rash
Papular rash erupted on abdomen, shoulders and later jaw line and forehead. Slightly erythematous in a few areas. No itching no oozing, no respiratory issues, no discomfort.
Excessive sweating in February, feeling of irregular heart rate, April chest discomfort , May tired and achy, June high diastolic BP, lower extremity pitting edema, July
Provider did not schedule my second dose at 28 days. I will receive my second Moderna dose at 32 days from a different provider.
Progressive pain in left arm (both bicep & forearm, pain in hand and numbness of index and middle finger.  Pulsating sensation in the arm. Rx issued on 01-31-2021 60 mg Prednisone and 600 mg Ibuprophen x 5 days.  Little improvement to level of pain and no change to numbness of fingers. ( as of day 3)
within 24 hours : fever for 12 hours, fatigue, loss of appetite within one week : excessive hair falling out for multiple days in a row within 2 weeks notable for missed menstruation and not pregnant
cramps and spasm Narrative:  hours after vaccine developed fever, headache, myalgia. 2 days following vaccine started getting cramping, L arm worse (vaccinated left arm). still has cramps day 3,.
Fever of 100.8, body aches, nausea. Advised to go to ER but Pt declined.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 17-10-2012 14:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Menses always 4-5 days. This menses (first since vaccine) is now on day 14! Flow not extremely heavy but continuous. Huge change from normal.