chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced vertigo within 15 minutes of administration of COVID 19 shot.  Her blood pressure was 97/73.  Five minutes later it was 123/83 and a third reading approximately 15 minutes after the original was 120/81.  The patient slowly felt better and was able to walk to find her companion.  She had a headache and decided to go home and forgo grocery shopping.  The next day she came in person to report experiencing tinnitus and mild headache still.  I sat with patient until she felt good enough to walk and then walked with her per her request to help her find her friend.  After about an hour of slowly getting better, but not good enough to follow through with her grocery shopping plans.  She decided to go home with her friend and rest and come back tomorrow to grocery shop and report back with any further symptoms.  She was feeling better enough to grocery shop and she was reminded to please fill out form for reporting purposes.
This spontaneous case, initially received from pharmacist on 09-Oct-2018, concerns a 2-year-old, child patient of an unspecified gender. On an unspecified date, the patient (under 4 years of age) was administered FLUCELVAX QIVc [dose, batch number, expiry date, route of administration and anatomical location: not reported]. No adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious. Update received on 25-Oct-2018: Significant case correction (IRD: 09-Oct-2018): The report type of the case was changed from 'invalid' to 'valid'.
Three weeks after the vaccine I developed a rash like Shingles. It started at my right shoulder and migrated to the left side. It progressed to my trunk and back. It was red raised and warm to the touch. I have had the Shingles Vaccine. It was not painful. The rash was everywhere all the same time. I had a Biopsy done on some of the rash and the results stated that it was a drug related rash. I tried Benadryl and a cream, but nothing helped. It got a little better after a week, it took three weeks for the rash to be gone. I had the second shot and had no trouble.
Nasal Swab positive/Covid treatment; Nasal Swab positive/Covid treatment; This is a spontaneous report received from contactable reporter (Nurse) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Aug2021 as dose 1, single (Lot number: FA7485), in left arm and on 02Sep2021 as dose 2, single (Lot number: Fc3182) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Covid", start date: 09Oct2020 (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; SLYND; XYZAL. Past drug history included: Percocet, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "not recovered" and all described as "Nasal Swab positive/Covid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2020) Positive, notes: Nasal Swab; (01Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure.; Sender's Comments: Based on the available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and both events VACCINATION FAILURE and COVID-19.
Headache & fever.; The chills so bad my body shook for hours, joint pain, nausea, muscle pain lasted for approximately 6-7 hours.; The chills so bad my body shook for hours, joint pain, nausea, muscle pain lasted for approximately 6-7 hours.; The chills so bad my body shook for hours, joint pain, nausea, muscle pain lasted for approximately 6-7 hours.; The chills so bad my body shook for hours, joint pain, nausea, muscle pain lasted for approximately 6-7 hours.; Headache & fever. My fever lasted a solid 3 days but my headache that started 4/15/2021 is still going on 4/20/2021, it was non stop; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 10:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had seasonal allergy and environmental allergy. Concomitant medications taken within two weeks of vaccination included montelukast (MANUFACTURER UNKNOWN), levocetirizine dihydrochloride (XYZAL), diphenhydramine hydrochloride (BENADRYL), cyanocobalamin (B12 VITAMIN) and ascorbic acid (VITAMIN C); all from unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 25Mar2021 at 10:15 (at the age of 45-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. On 15Apr2021 at 15:00, the patient experienced headache and fever. The patient also experienced chills so bad that her body shook for hours, joint pain, nausea, muscle pain lasted for approximately 6-7 hours. Her fever lasted a solid three days but her headache that started 15Apr2021 was still going on 20Apr2021, it was non stop Thursday afternoon till Sunday afternoon, the patient at the time of report occasionally got an hour or two without the headache but it kept coming back. The event headache resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of headache which included doctor visit on 19Apr2021. The clinical outcome of the events chills so bad that her body shook for hours, joint pain, nausea, muscle pain that lasted for approximately 6-7 hours was resolved on 15Apr2021. The clinical outcome of the event fever, that lasted a solid three days was resolved on 18Apr2021. The clinical outcome of the event headache that started 15Apr2021 was still going on 20Apr2021, it was non stop Thursday afternoon till Sunday afternoon, the patient at the time of report occasionally got an hour or two without the headache but it kept coming back was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 07/09/21 community resident came to clinic with parent to obtain Covid Vaccination. Individual is not a patient of the health center. The nurse administered 2nd Dose from Pfizer lot EW0185. Patient did not exhibit or complain of any adverse symptoms during observation period.    On 07/20/21, back office identified that recipient's birth date. This makes the recipient only 11 yrs and 3 months old; ineligible for Pfizer vaccination for which minimum age is 12 years.   Phone call to parent parent. Parent confirmed age of recipient and birth date. She stated that "all has been well, he has had no side effects".
04Jun90 pt vax;  next day devel large hard, hot localized swelling size of softball in rt arm.  Noted chills & fever.
Red rash on Left arm below injection site 9 days after  1st dose. Shoulder red 3? across 5-6? down arm. 2nd splotch of  Redness wrapped around under arm. Some itching after daily shower . Swelling caused tightening of skin, slight hardness. Injection site felt when touched.     Faded 20 days later ( Saturday March 6,2021)
Continued reaction from the 1st vx: Heart rate became higher. I used to always stay below 70 BPM, now it's permanently increased and stays above 100.
severe chills and shivering, headache, major lower back pain.  lasted 12 hours, then another 12 hours before headache subsided.
After second Pfizer vaccine shot, left arm became sore and remained sore for 2 months and still sore; Diagnosed with Tendonitis which never had before.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:00 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prostate cancer" (unspecified if ongoing), notes: Prostate cancer 5+ years ago treated with cyberknife; "Kidney stones" (unspecified if ongoing), notes: History of kidney stones. Concomitant medication(s) included: ALLOPURINOL; HYDROCHLOROTHIAZIDE; POTASSIUM CITRATE.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 13:00, outcome "not recovered", described as "After second Pfizer vaccine shot, left arm became sore and remained sore for 2 months and still sore"; TENDONITIS (non-serious) with onset 24Mar2021 13:00, outcome "not recovered", described as "Diagnosed with Tendonitis which never had before.". The events "after second pfizer vaccine shot, left arm became sore and remained sore for 2 months and still sore" and "diagnosed with tendonitis which never had before." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: diagnosed with tendonitis. Therapeutic measures were taken as a result of pain in extremity, tendonitis.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Advil, doing exercises and heating pad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929  Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT) (no more information was provided).   No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009898: US-009507513-1805USA009899: US-009507513-1805USA009900: US-009507513-1805USA009901: US-009507513-1805USA009902: US-009507513-1805USA009903: US-009507513-1805USA009904: US-009507513-1805USA009905: US-009507513-1805USA009906: US-009507513-1805USA009907: US-009507513-1805USA009908: US-009507513-1805USA009909: US-009507513-1805USA009910: US-009507513-1805USA009911: US-009507513-1805USA009912: US-009507513-1805USA009913: US-009507513-1805USA009914: US-009507513-1805USA009915: US-009507513-1805USA009916: US-009507513-1805USA009917: US-009507513-1805USA009918: US-009507513-1805USA009919: US-009507513-1805USA009920: US-009507513-1805USA009921: US-009507513-1805USA009922: US-009507513-1805USA009923: US-009507513-1805USA009924: US-009507513-1805USA009925: US-009507513-1805USA009926: US-009507513-1805USA009927: US-009507513-1805USA009928: US-009507513-1805USA009929: US-009507513-1805USA009930: US-009507513-1805USA009931: US-009507513-1805USA009932: US-009507513-1805USA009933: US-009507513-1805USA009934: US-009507513-1805USA009935.
Hospitalized with acute respiratory failure with Hypoxia, pneumonia, sepsis. Discharged improved, stable to home health
Enlarged lump glands under right arm.  That only lasted about a week but both breasts became sore.  They are now  enlarged and very sore.   I did not have this symptom before being vaccinated. I made an appointment with my gynecologist.
Subsequent to receiving vax the pt developed a papular, vesicular rash consisting of a total of 16 skin lesions scattered on her face, neck, trunk and legs. The pt was afebrile.
redness/light swelling on left side of face starting day after administration lasting multiple weeks. self limiting.
The shot record was read by another staff member and I pull the shot without revising the shot record as well. I did not realize I have given a Kinrix until I went to put it in.
Vx given  using sterile water/reconstituted using sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 2-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution 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 Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments: The health care professional did not had information regarding the vaccine lot number, patient's initials, gender, nor vaccination date.  For the date health care professional mentioned as past weeks. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. Additional Supportive Information: The patient was administered a dose of Rotarix but dose was reconstituted using sterile water instead of the provided diluent, which led to wrong solution used in drug reconstitution. This case had been linked with US2023032793, reported by the same reporter.; Sender's Comments:  US-GSK-US2023032793:Same reporter
after receiving vaccine pt states he became very nauseous after 5 minutes, pt given snack and drink with no improvement  brought back to OBS area, vs as noted,. pt cont to feel nauesous  not vomiting at present time.,  pt states having anxiety with everyone standing around him. pt states had three cups of coffee this AM with nothing to eat for a few hours.  pt feeling better after less people around and sitting on stretcher. refusing more snacks initially but then after first attemp at standing and feeling "woozy" per pt  pt agreed to try some crackers, pt tolerated well and refused further nausea.  second attempt at standing pt denies feeling lightheaded or woozy and feeling better and would like to go home.  pt aware BP is elevated and states he is super anxious about everything going on at present time and the environment in general. pt enc to get checked out at primary care physician for increased BP as noted  pt agreed  pt amublated to exit without diffiuclty at 1511.  vs: 1435 159/97 hr 67 rr 18 o2 97, 1440 bp 147/108 hr 61 rr 18 o2 100, 1445 bp 120/91 hr 72 rr 18 o2 99, 1450 bp 147/85 hr 61 rr 20 o2 99 1455 bp 128/94 hr 65 rr 18 o2 98, 1500 standing at bedside bp142/101 hr 66 rr 20 o2 99  1510 standing at bedside 2nd attempt bp 153/100 hr 71 rr 20 o2 99
Initial pain at injection site. Pain/soreness at injection site spreading to lower arm and proximally to shoulder area.
Patient was seen for 16 Month WCC, He received varicella and PCV 13 30 minutes after patient was noted to severe allergic where his skin flushed, heart rate increased with hives on his face, chest and abdomen. No airway compromise or edema noted0 Patient was given Epi Pen and Benadryl. Provider followed up via telephone with mom on 03/22/2023.
This spontaneous report as received from an other, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # J000430, expiration date 10-APR-2013) (dose and route were reported). Concomitant medications were not reported. On an unknown date the patient experienced an adverse reaction to ZOSTAVAX. The outcome of the adverse reaction was unknown. The relationship between the ZOSTAVAX and the adverse reaction was not reported. Additional information has been requested.
shaking; vomiting; diarrhea; his legs had locked up; Initial information received on 09-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 67 years old male patient who experienced shaking (tremor), vomiting (vomiting), diarrhea (diarrhoea) and his legs had locked up (restless legs syndrome), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included Influenza vaccine.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 14-Dec-2019 at 11 am, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: U306AA and expiry date: not reported) via unknown route in the left arm.  On 14-Dec-2019 at 16:30 pm the patient developed a non-serious shaking (tremor), vomiting (vomiting), diarrhea (diarrhoea) 5 hours 35 minute following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that, patient wife called the ambulance and when the ambulance arrived at the house the patient wife said he could barely get up out of bed. Caller stated his legs had locked up (Restless legs syndrome) and could move his legs with assistance. He went to the Emergency Department and received IV fluids.  Final diagnosis was stated his Restless legs syndrome, diarrhea, vomiting and shaking.   An unknown corrective treatment was received (IV fluids).  The patient outcome was reported as unknown for all events.
Varicella Rash, mild fever, moderate puritis. Onset 03/12
Large red, hot mark around injection site, hard and tender to the touch. I also experienced achiness and headache day of and day following my second shot but I expected that. I?m also a breastfeeding mother, my son is 6 months old and he was extremely sleepy the day after the vaccination (5/8/2021) he seems back to normal today (5/9/2021).
The nurse stated she reconstituted the 5 to 11-year-old  Pfizer COVID-19 vaccine with 1.8mL of 0.9% of normal saline instead of 1.3mL.
had dizziness & felt backwards w/quivering of lips w/short period of unconsciousness 20 seconds can't remember what happened;pt recovered in 2min;
Extremely sore around injection site for over 2 weeks. Also, very itchy and tingly a few times.
This spontaneous report was received from a nurse and refers to a 67 year old female patient. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 17-FEB-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # L017265, expiration date: 10-JAN-2017) for prophylaxis (Expired product administered). No adverse effects were reported. No further information reported. Additional information has been requested.
This is a non-serious spontaneous case initially received from a physician on 30-Oct-2018, concerning a female patient of an unspecified age. On an unspecified date, the vaccine underwent temperature excursion for 2 hours, reaching a minimum temperature of 34-degree Fahrenheit. It was the first-time excursion. On an unspecified date, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252225 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse events after administration. This case is linked to 201805100 (same reporter).
Information has been received from a physician concerning a 69 year old female patient who was vaccinated with a dose of Zostavax. It was reported that the patient experienced joint pain, nausea and fatigue after vaccination. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
24 hours after vaccination patient experienced red, blotches approx. 3"x6" vertical from vaccination site. Some swelling but improving. No itching.
PT HAD A BREAKOUT OF COLD SORE ON LIP AND RASH AROUND NECK AND CHEST 2 DAYS AFTER RECEIVING VACCINE, THEN A WEEK AFTER A SMALL RASH COMING ON RIGHT EYE BELOW EYEBROW.
Patient was 4 years old  at time of covid vaccine administration. No adverse events occured.
On Thursday, 1/27/22, Patient came to HCF Covid-19 Vaccination Site for his Covid-19 Pfizer booster vaccine. During assessment questions, client stated he experienced "dizziness" during his first and second Covid-19 Pfizer vaccines. Client denied any medical conditions, medications or drug allergies. Client was to be a 30 minute observation. RN 1 vaccinated client in anti-gravity chair with Pfizer (LOT #: FK9729) in his left deltoid at 1:15 PM. At 1:21 PM, while waiting in Observation Area, client stated to RN 2 he felt "dizzy." Client denied any pain or shortness of breath. At 1:22 PM vitals started, BP: 136/72, HR: 62, O2 sat: 98%, RR: 16, skin: pink, warm and dry. RN 2 offered client a water bottle and cookies. Client accepted and consumed water and cookies. Client stated the last time he ate was at 10 AM. At 1:28 PM, BP: 126/68, HR: 65, O2 sat: 98%, RR: 16, skin: warm, pink and dry. Client stated he felt "much better" and his sensation of dizziness was completely gone. At 1:45 PM, client was able to stand up and not feel dizzy or nauseated. No further interventions needed. Client was educated by RN 2 on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. At 1:50 PM, client left vaccination site with a steady gait.
On 5/16/20 developed new rash on left shoulder, diagnosed with zoster and started on acyclovir and gabapentin.  On 5/21/20 acyclovir was switched to valacyclovir.  As of 6/5/20 patient reported that zoster rash improving but still experiencing nerve irritation and pain.
not feeling good at all; joint pain; back pain; a little scratching and swelling in the back of my throat; a little scratching and swelling in the back of my throat; clammy in bed; This is a spontaneous report from a contactable consumer (patient). A 65 (unspecified units) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via unspecified route of administration on 28Jan2021 as single dose for covid-19 immunization. The patient medical history included sciatica pain and inflammation arthritis. Concomitant medications were not reported. On 29Jan2021 (on the next day of vaccination), the patient was not feeling good at all and on an unspecified date in 2021, stated she experienced joint pain, back pain and "a little scratching and swelling in the back of my throat". She stated that one night she was "clammy in bed". She wanted to know if she could take Benadryl before the 2nd dose of covid vaccine. She wanted to know whether the second dose of covid vaccine is more potent than the first dose. The outcome of the events was unknown.  Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.