chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am immunosuppressed; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that "I am immunosuppressed and I want to participate in your booster trial if you have one. I have already taken both of my Pfizer Covid shots." The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a 39 yo female who recieved a High-Dose Quadrivalent flu shot (65+). Pt has reported no adverse symptoms.
pt. presents with a headache.  HX: DM Type 1; BG: 282;  onsite medic present.  pt. declined EMS/ER.  pt. decided to have spouse come pick her up to take her home.  pt. left her vehicle at the vaccination site.  BP: 131/78, HR: 86: RR:18
Pt developed hives, hyperventilation, SOB, funny taste in mouth, cough approx. 1 1/2 hours after vaccine admin.
Subsequent to receiving vax the pt developed muscle aches, joint pain and fatigue. Additional information received reports that the pt recovered from this experience on 12/20/1999.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Error: Infection / Cellulitis (diagnosed by MD)-
Patient has a bump under right arm at injection site and experienced some itching. Symptoms started the day of the vaccine and are still present.
? 1st does Pfizer was on 04/28/21, 2nd 05/19/21, patient was only 15yrs old at the time.  No adverse affects. Just reporting age at time of their shot.
Pain at both injection sites, but greater on left side (PPSV23) than right (Tdap) for 3 days. Hot, red area approximately 3 inches long and 2 inches wide close to PPSV23 injection site (area of injection and distal from it), painful to touch for two and a half days. Nausea, low grade fever (100F), and other flu-like symptoms for approximately 24 hours.
Fever, shoulder pain, back pain, chills, fever Narrative: day1 - back pain and shoulder pain; Day 2 - chills; day 3 - fever; day 4 - fever; day 5 - fever; tylenol used for minor pain relief; no further symptoms noted
Arm is swollen, red, warm to touch pt had sweating, chills, nausea and ached all over.
received the COVID-19 Vaccine really high, which was almost given into the shoulder bone / this is a complete medication error.; Vaccine really high and caused blisters she presumes at the injection site.; This is a spontaneous report from a contactable other HCP. This other HCP reported for a female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left deltoid at single dose for COVID-19 immunization on 09Jan2021 at 10:10 am. Patient's Medical History included seasonal allergies.  Relevant concomitant drugs were unknown. The patient  received the COVID-19 Vaccine really high, which was almost given into the shoulder bone and caused blisters she presumes at the injection site. It was almost on the very top of the shoulder. The blisters appeared one day after the injection on 09Jan2021. The patient presented to the clinic on 11Jan2021, with kind of a cluster of blisters; one blister was kind of longer than the other at about 7mm's. Patient  took ibuprofen and had been guarding her shoulder. The patient was a physician and cardiologist, she was worried that the vaccine was not effective. The blisters were reported as improving. Reporter stated that she could send a picture of these blisters, if needed.  The patient stated that the nurse who gave this COVID-19 vaccine injection to this patient, had been pulled from giving any more vaccines. This was a complete medication error. The patient removed the band aid from where the COVID-19 vaccine had been given and there were the blisters. The AE was not required a visit to Emergency Room, nor Physician office. No other Vaccinations received other than COVID-19 first dose were given in the last 4 weeks. No other AE's related to other vaccinations.  The information on the lot/batch number has been requested.
2/18/04-pm client's L arm started to swell. Today 2/19/04 a cellulitis in L arm (upper arm) warm, swollen, red to touch. No c/o pain client able to sleep at night. Client received scripts for Tylenol and Keflex and to put cool compress on area.
Information has been received from a registered nurse concerning a 12 year old female who on 24-MAR-2009 was vaccinated SC with VARIVAX (Merck) (lot # 662459/1784X) into the left arm.  On 25-MAR-2009 the patient developed large area of redness at injection site.  The patient called the office on 26-MAR-2009 and was prescribed cool compresses, MOTRIN and BENADRYL.  This is one of several reports from the same source.  Additional information has been requested.
Approximately 3 hours after the vaccination, she noticed her left eye was itching and swollen
Initial report received from a Healthcare professional (Nurse) on 03 July 2012. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE intradermal (batch number, site of administration were not reported) on an unspecified date. The reporter stated that, the receptionist of the clinic had a stain on her arm where she received FLUZONE intradermal. It looked like her skin was bleached and the stain is about the size of a dime. The patient had a lot of itching several days after being immunized. Corrective treatments and laboratory investigations were not reported. The outcome was not reported. Documents held by sender: none.
This is a spontaneous report from a contactable consumer, the patient. A seventy-two-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of seventy-two-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to intravenous contrast media (reported as intravenous dye). Concomitant medications taken within two weeks of vaccination included phenytoin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and amlodipine (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 12Mar2021 at 09:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Next day, on 07Apr2021 at 10:00, the patient experienced numbness in left leg, he could hardly walk, seemed to be dragging left foot. This lasted for 3 days, (almost stroke like). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events next day numbness in left leg, could hardly walk, seemed to be dragging left foot, this lasted for 3 days, (almost stroke like) was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
I do have the ringing in my ears that's not going away, It's like a little bee stuck between my brain and all; My left arm shoulder which never hurt before is achy when I sleep at night, it aches at certain position; it just 'hurt in' the joint area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "Neuropathy peripheral" (unspecified if ongoing); "Pacemaker", start date: 2001 (ongoing), notes: I have a pacemaker installed and that thing is going on for 20 years. The patient took concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "I do have the ringing in my ears that's not going away, It's like a little bee stuck between my brain and all"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "My left arm shoulder which never hurt before is achy when I sleep at night, it aches at certain position"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "it just 'hurt in' the joint area".  Additional information: Patient stated that ringing in my ears that's not going away, it's like a little bee stuck between my brain and all (Clarification unknown), that I do notice and then my left arm shoulder which never hurt before is achy when I sleep at night, it aches at certain position then it eventually goes away and then I fall sleep, so that's my two complaints, it's in my left shoulder and I am right handed. So strange I 'didn't use' and my left hand that much or left arm that's a little strange that thing is all of a sudden aching right where the shot was, it just 'hurt in' the joint area but not where the shot was put in.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax JUN97 & 24hr p/vax pt devel edema of the eyelids & an itchy rash over entire body;pt recovered;
hallucination which lasted for 2 1/2 weeks; fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucination which lasted for 2 1/2 weeks) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 14M20A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucination which lasted for 2 1/2 weeks) (seriousness criterion medically significant) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucination which lasted for 2 1/2 weeks) and PYREXIA (fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medications was not provided by the reporter Treatment information was not provided  This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hallucination. The event on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was as event occurred after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-358365 (Patient Link).; Sender's Comments: This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hallucination. The event on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was as event occurred after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Period started normally after vaccine but lasted for nine days. Normal period is only three days.; This is a spontaneous report from a contactable consumer. This 30-year-old female consumer (patient) reported that: A patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 13:00 (Batch/Lot Number: Ew0151) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced Period started normally after vaccine but lasted for nine days. Normal period is only three days on 17Apr2021. No treatment was received. Patient did not have Covid prior vaccination and also patient did not Covid tested post vaccination. There was no other vaccine in four weeks. The outcome of event was recovered.   No follow-up attempts are possible. No further information is expected.
Dizziness to the point that walking is difficult. I've gotten the flu shot every year for decades and this is the first time it's happened. There has been no change in my routine otherwise.
Information has been received from a registered nurse, via a company representative, concerning a pt age and sex unknown, who on an unspecified date was vaccianted route unknown with a second dose of Pneumococcal 23v polysaccharide vaccine. The pt had previously received Pneumococcal 23v polysaccharide vaccine, but this history was unknown when the pt was given the second dose. Subsequently, on an unspecified date the pt experienced arm soreness. Unspecified medical attention was sought. The pts outcome was unknown. No product quality complaint was involved. Additional information has been requested.
As described by patients husband, she has general muscle pain and weakness, not restricted to injection site/arm which has lasted approximately a year so far.
This spontaneous report was received from a male physician between 65 and 67 years old via a company representative reporting on himself. The patient had received PREVNAR 13 in approximately 2014 reported as "the last year prior to the knee surgery and the PNEUMOVAX 23". The patient stated that he was in hospitalization on an unspecified facility for knee replacement surgery this past summer 2015. While still an inpatient, on an unspecified date in 2015, the facility administered to the patient a dose of PNEUMOVAX 23 (lot number, expiration date strength, dose and route were not provided). Concomitant medication was not reported. About 24 hours after receiving the PNEUMOVAX 23, the patient experienced pyrexia reported as "a fever". The patient was concerned as he feared an infection resulting from the surgery. But, there was no infection from the knee surgery. The outcome of pyrexia was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX 23 to pyrexia. This is one of several reports from the same source. Additional information has been requested.
01-28-04 OV for #2 HB. Reports evening of 12-24-03 patient received HB #1 and Td booster.  Had facial redness.  On 12-25-03 used wet cloth to face for comfort. Complained of face red, swollen, puffy and hot.  Also complained of ankle swelling.  Did call ER but no visit she was told she had to be seen, says resolved by next day.
At the site of MMRV injection on (R) thigh developed about 1.5" oval redness, mild swelling, local warmth and tenderness. These symptoms developed this am. No itching, no systemic symptoms.
Mother gave child acetaminophen prior to sending to day care. Day care called mother mid-morning, stated child had been fussy, inconsolable, temp 100.3. Mom brought child to doctor's office at 4:15 pm temp 99.1 rectally. Child also had small bruise to (R) thigh at injection site.
Shingrix lyophilized vial was reconstituted with sterile water; Shingrix lyophilized vial was reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's comment: The pharmacist inquired regarding Shingrix dosage. Shingrix lyophilized vial was reconstituted with sterile water. The pharmacist was unsure if the Shingrix lyophilized vial was reconstituted with unknown diluent and administered or if the vial was just missing.  The RPH (Registered pharmacist) was unable to provide any details of vaccine or if any patient was involved. The reporter did not consent to follow up. Additional Supportive Information: The patient received Shingrix which was diluted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
I received my first shot and exactly 7 minutes into the shot I had a cold chill come across my chest and them my tongue felt too big for my mouth and I could not talk correctly. I left after my 15 minutes not knowing what was happening and my tongue did not become normal again for around 4 hours.  When  I went for my second shot 28 days later, I requested a nurse to sit next to me and monitor me as I had later found out that was not a normal effect from the shot and I was then told I could not receive my second shot as my symptoms from the first shot were signs of an allergic reaction.
Office manager reported that improperly stored doses of VAQTA were administered to patient on an unspecified date.; No adverse affects reported.; This spontaneous report was received from an office manager referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) (lot# S009562, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019; strength, dose detail  and route were not reported) for prophylaxis (improper storage of product in use). The hepatitis a vaccine, inactivated(VAQTA) was exposed to temperature of 35.1 fahrenheit degree for 5 hours. No previous temperature excursion. No adverse effects were reported. Data logger was involved. The outcome of the event was unknown.
For both dose 1 (EW0183 - 8/4/2021) and dose 2 (FF8839 - 10/2/2021), I have experienced left side facial numbness, left arm numbness and pain under my left breast.   After the first does I had intermittent facial numbness for over a month, that is why I put off having the second dose for 2 months and now that is all back again.  Had second dose yesterday and the numbness started on 10/3/2021 at 7am.
passed out at vaccination facility.was taken by ambulance to the ER; started to feel strange and tried to flag someone after 10 minutes of  first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out at vaccination facility.was taken by ambulance to the ER) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.     On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out at vaccination facility.was taken by ambulance to the ER) (seriousness criterion medically significant) and FEELING ABNORMAL (started to feel strange and tried to flag someone after 10 minutes of  first dose). At the time of the report, LOSS OF CONSCIOUSNESS (passed out at vaccination facility.was taken by ambulance to the ER) and FEELING ABNORMAL (started to feel strange and tried to flag someone after 10 minutes of  first dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal. On an unknown date, Electrocardiogram: normal. On an unknown date, Laboratory test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taken to ER after the patient passed out.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-089511 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-089511:Case for patient
No event; Improperly stored vaccine; This spontaneous report was received from a physician and refers to a 2 month old female patient. Patient had none concurrent conditions or medical history. Concomitant medications included hepatitis b vaccine (manufacturer unknown), diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) and PEPCID (unspecified component).     On 06-JUN-2023, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968386, expiration date: 23-MAY-2024, oral (po) (strength not provided) as prophylaxis, which underwent a temperature excursion and there was a concern about vaccine viability. It was reported that it was believed that there was sensory issue in the alarm; therefore, temperatures were monitored with a back up logger. It was seen that temperature was in range, and the new data logger was kept using. Vaccines that underwent the temperature excursion were returned. No adverse effects were seen.
Small clusters of reddish pink bumps/hives, some raised and some under skin on torso (neck, shoulder, back, stomach, hip).  Most are itchy but some are not.  I noticed a cluster of 3 bumps/hives on the right shoulder when I returned home and then checked the rest of my body.  There were other small clusters and some single bumps (~ 15 bumps in total).  In the evening on 3/20/21, my left check felt itchy and the back of my scalp near the neck was itchy and pink.  The next morning on 3/21/21 another cluster of 7 bumps/hives appeared on my back and a few other single bumps on my back.  I took one Benadryl tab the night of 3/21 plus used Benadryl cream on the bumps/hives.  On 3/22, I called my insurance 24 hour nurse line for advice.  I was advised to keep taking the Benadryl as needed to try to lower the potential histamine response plus drinking lots of water.  We reviewed the CDC guidance and we agreed my issue did not meet the criteria to prevent taking the second Moderna dose at this time since the bumps/rash was only topical and I did not experience swelling or wheezing in addition to the bumps/hives.  As of today 3/23, the bumps have not gone away and are still itchy.  They appear to be darker in color.  I will continue to use the proposed Benadryl protocol I described and plan to start the same regimen preventively after I get the second dose in ~ 4 weeks.