chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored doses of VARIVAX (Merck) (lot # K010338, expiry date 22-JUL-2016; lot# K011801, expiry date 21-AUG-2016; lot # K016130, expiry date 21-SEP-2016; lot # K026387, expiry date 15-DEC-2016; lot#L001333, expiry date 13-JAN-2017; lot # L002871, expiry date 27-JAN-2-17; lot # L006383, expiry date 25-FEB-2017; lot # L015049, expiry date 29-SEP-2017; lot # L019124, expiry date 27-MAY-2017; lot # L019130, expiry date 27-MAY-2017; lot # reported as L023588, expiry date 26-JUN-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pain in right arm.  Nausea and tiredness.  Following day pain to right side of body.  Ear pain, breast pain, back/lung area, leg pain.   Congestion that won?t go away.  These symptoms have not gone away as of today, August 25, 2021.
Developed full body dermatographism after no previous history with the condition. Pressure applied to my skin results in an itchy welt that remains for 30-60 minutes. Unable to see my PCP at the moment, managing symptoms with antihistamines and lifestyle changes.
pt recvd vax; felt hot p/ vax then all day T 105.8; apap did not help; won't sleep;
Induration at the injection site; Arm tenderness; Half the dose ran down her arm; Half the dose ran down her arm; Needle became detached, half dose ran down the arm; This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site induration (1st dose of Shingrix received on 6th May 2022, refer case US2022116391).   On 5th August 2022, the patient received the 2nd dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced injection site induration, pain in arm, exposure via skin contact, inadvertent exposure to vaccine and accidental underdose. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site induration and pain in arm were not recovered/not resolved and the outcome of the exposure via skin contact, inadvertent exposure to vaccine and accidental underdose were unknown.  It was unknown if the reporter considered the injection site induration and pain in arm to be related to Shingrix.  Linked case(s) involving the same patient: US2022116391.  Additional Information: GSK Receipt Date: 08-Aug-2022. Reporter's Comments: This case was reported by the physician (MD) who was the patient herself. The patient received second dose of Shingrix on an unknown arm and again experienced arm tenderness and an induration at the injection site. The reporter reported that during the administration of the second dose the needle became detached from the syringe and half the dose ran down her arm. Spoke per package insert and content. Outside phone number for GlaxoSmithKline Medical Information given for future reference and warm transfer provided. The reporter consented to follow up. Additional Supportive Information: During the administration of the second dose the needle became detached from the syringe and half the dose ran down her arm, which led to exposure via skin contact, inadvertent exposure to vaccine and accidental underdose.; Sender's Comments:  US-GSK-US2022116391:Same reporter.
On Saturday,7/17/21,  received her second dose of Pfizer Covid-19 vaccine (LOT #: EW0191, exp: on 8/2021) at 12:20 pm on her left deltoid. During assessment questions, client denied any underlying medical conditions or allergic reactions and was to be a 15 minute observation. At 1:25 pm, while waiting in Observation Area with her significant other, client stated to RN , she is feeling "anxious and dizzy" and stated she did not experience this reaction after her first dose. Client stated to RN  & Lead PHN  she does not take any medications. At 1:27pm, client was seated in the anti-gravity chair and vitals were offered but refused by patient. Client was given a bottle of water, juice and emesis bag and was asked to wait in the Observation Area until she felt better. After 20 minutes in the anti-gravity chair, client stated to RN & PHN  that she was feeling much better and denied anymore anxiousness or dizziness. No further interventions needed. Client was educated by RN  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. Client left vaccination site with a steady gait at approximately 2:00 pm.
Pt received shot number 4 of the Anthrax series in his left arm, vaccine site sore to the touch, looks like it is bruised (size of hafl dollar), Received shot 22 Oct 04, First time patient had a reaction.  Color of site yellow, blue and purple. No other vaccines given this day or 4 weeks prior.
Day after felt nauseous, joints ached, tired, lost appetite.  Took 2 Tylenol in evening.  Feeling back to normal today 2/20/2021
t105 for 4 days; rash all over cried a lot; glassy eyed, breathing real heavy, staring into space like didn't realize anyone was talking; seen by MD 23MAR93 & was treated for ear infection; said other sx were a reaction to MMR;
SHINGLES- SEVERE PAIN IN HIP AND LEG.  FOLLOWED RASH 3-4 WEEKS PREVIOUS.
Spasms; Paresthesia; Fever; Diarrhea; Nervous system issues; Weakness as legs could barely move; Nervous zapping in my brain and body; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included antibiotics from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 08:00, the patient experienced spasms, paresthesia, fever, diarrhea, nervous system issues, weakness as legs could barely move, nervous zapping in brain and body. On an unknown date in 2021, the patient underwent blood test and the result was unknown. On 13Apr2021, the patient underwent COVID test (nasal swab) and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if patient received any treatment for the events. The patient reported that nobody knew what to do. They were doing blood work. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events spasms, paresthesia, fever, diarrhea, nervous system issues, weakness as legs could barely move, nervous zapping in brain and body was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Symptoms: numbness/tingling and cold skin all over body (both sides of body), headache, facial droop, blurry vision. Stoke, CVA.
Patient was seen in office by PCP on 03.03.20 where Kinrix and Proquad immunizations were administered to the left thigh. Father stated during return visit on 03.10.20 he noticed the immunization site was warm to touch approx. 4-6 hours after 03.03.20 visit along with discoloration including redness and bruising. on 03.04.20 the pt was taken to the ED for allergic reaction to antibiotic prescribed at the same visit along with swelling progression to immunization site. ED note stated  "There is an approximately 3 cm in diameter erythematic and warm, slightly elevated rash to the left lateral thigh. No pitting edema present."  Pt was examined during return follow up visit by PCP on 03.10.20 where it was noted the swelling had completely dissipated, only leaving a slight purple-blue hue at injection site.
My ears began ringing and it has not stopped. It wakes me up at night. It has been constant ringing. Today is 12/30/20.
Upon entering vaccine administration information from today's clinic into immunization registry, I noticed the patient already received 2 doses of this vaccine.
Received call 16 June 2022 at 10:28am from above identified patient. Patient told she was in the ED the night before. Patient did not identify which ED location. Patient still having extreme pain in arm post-vaccine. ED Dr told her that the nurse that administered her COVID-19 vaccination the week prior had administered it in the, "wrong location." Patient expressed being on medications for pain and also now has to begin therapy to regain use of arm.   Additional info:  Vaccinating RN:  Patient DOB:  Patient AV QR:  Patient Email:  Patient confirmed in  Vaccine: Pfizer COVID-19 Vaccine -Tris-sucrose formula  Lot#: FM7553   Exp: 09/30/2022  Route: Intramuscular  Site: LD - Left Deltoid  Dose #: 4  Completed internal incident report for documentation. After consulting with  Medical Director, Dr. he recommended our legal counsel be made aware.  When incident report was written (6/16/2022 - patient has not requested additional follow up.)  On 7/12/22, Patient came back to Mobile POD unit. On 7/13/22 HCPH left voicemail to discuss how patient was doing.
Within 24h, patient started coughing and wheezing. Was hospitalized approximately 48h after vaccination with FLUMIST. She was not a known asthmatic.
vertigo -- feels like motion sickness and when "I" lie down the ceiling appears to be spinning; Slight discomfort at the location of the shot (left arm); Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Medical history included parkinsonism, diabetes, sleep apnea, fatty liver, autoimmune disorder unknown high rheumatoid arthritis (RA) factor and positive antinuclear antibodies (ANA), penicillin allergy and latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included carbidopa/levodopa (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), fish oil (OMEGA 3) and multiple vitamin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown dates and unknown if ongoing. The patient previously received primidone (MANUFACTURER UNKNOWN) and rotigotine (NEUPRO PATCH) both for an unknown indication from an unknown dates and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 10Feb2021 at 14:45 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. On 04Mar2021 at 04:30, the patient experienced vertigo which felt like motion sickness and when she lied down the ceiling appears to be spinning, nausea, headache slight and discomfort at the location of the shot (left arm). 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, slight discomfort at the location of the shot (left arm), nausea and headache were not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse referring to a patient of unknown age and gender. On 04-FEB-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K018173, expiration 10-JAN-2016, dose was not reported) subcutaneously (Expired vaccine used). No adverse effect was reported. Additional information has been requested.
Had the vaccine on 2/12/21, was doing okay, had nausea and chills.  Then on Friday 2/26/21 felt like she was hit with a ton of bricks, and went to the Urgent Care to do a COVID test, and they told her they could not read it on 2/27/21.  She went to Hospital ER last night and had another COVID test and was diagnosed with the COVID virus, and told to go in the morning for an infusion.  Went this morning to Hospital Infusion center where they gave her an infusion to fight off the virus.    They told her to wait 90 days before she receives the 2nd vaccine injection.
Initial misuse report received from a healthcare professional on 11 June 2013. A 3-months-old patient was given MENACTRA vaccine inadvertently. No adverse event was reported. List of documents held by sender: none.
Client was observed dizziness and fainting in the observations area, and lost consciousness for 1 second, client was accompanied by mother and didn't fall or hurt, EMT and NP assessed clients, VS stable, client stated that she didn't eat lunch today, provided client with water and snacks, client recovered and went home with mom.
Cellulitis; Tenderness in lower axillar on the left side; Firmness at the injection site; Swelling at the injection site; Redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of CELLULITIS (Cellulitis) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), AXILLARY PAIN (Tenderness in lower axillar on the left side), VACCINATION SITE INDURATION (Firmness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, CELLULITIS (Cellulitis), VACCINATION SITE INDURATION (Firmness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and AXILLARY PAIN (Tenderness in lower axillar on the left side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant medications were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
I63.9 - Ischemic stroke  I63.9 - Cerebral infarction, unspecified I61.9 - Nontraumatic intracerebral hemorrhage, unspecified
parents reported pt had temp 2PM kept rising until reached 106-2:00-3:00AM;
Fatigue on the body, numbness in my left foot, rash in the area of vaccination.
Off-label use (due to interchange); Interchange of vaccine products; Booster; were able to withdraw 4 doses only with no other left pre-drawn doses/adult Pfizer COVID-19 vaccine that was diluted with 1.8mL of correct diluent and instead of 6 doses they only got 4 doses; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 73-year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Dec2021 (Lot number: 330308D, Expiration Date: 28Feb2022) at the age of 73 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (Dose: 1, Lot number: 021B21A), administration date: 03May2021, when the patient was 72 years old, for COVID-19 immunization; Moderna covid-19 vaccine (Dose:2, Lot number: 045B21A), administration date: 03Jun2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 16Dec2021, outcome "unknown", described as "Off-label use (due to interchange)"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 16Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "Booster"; INCORRECT DOSAGE ADMINISTERED (non-serious) with onset 16Dec2021, outcome "unknown", described as "were able to withdraw 4 doses only with no other left pre-drawn doses/adult Pfizer COVID-19 vaccine that was diluted with 1.8mL of correct diluent and instead of 6 doses they only got 4 doses".  additional information: Caller is a nurse at withheld, reporting an event where they have diluted the vial of Pfizer Biontech Covid vaccine purple top with 1.8mL of diluent.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101812501 Same reporter / drug / event, different patients.;US-PFIZER INC-202101815604 Same reporter / drug / event, different patients.;US-PFIZER INC-202101815603 Same reporter / drug / event, different patients.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Stroke-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Vomiting-Mild
Skill induration at left hip/thigh-7/9cm with red, inflammed skin. No tenderness to palpation. Right hip: 2.5-3cm circular red skin induration. Itching present.
A serious spontaneous report of anaphylactic reaction has been received from a registered nurse concerning an adult male of unknown age, subsequent to FLUMIST along with Yellow Fever vaccine and TWINRIX vaccine. The patient's medical history and concomitant medication were not reported. The patient received FLUMIST along with Yellow Fever vaccine and TWINRIX vaccine on an unknown date. The patient received a total of one dose of FLUMIST before the onset of the event. The patient experienced the event of anaphylactic reaction, hives, wheezing and bradycardia, within 20 minutes after FLUMIST, Yellow Fever vaccine and TWINRIX vaccination administration. He was treated with two doses of epinephrine. The outcome of the event of anaphylactic reaction was recovered. The reporter assessed the event of anaphylactic reaction as related to FLUMIST, Yellow Fever vaccine and TWINRIX vaccine. On 30-Sep-2009, additional information was received from the reporter: she submitted a VAERS report to the Center of Disease Control.
Significant pain in the sciatic nerve in the back and down to the lower left leg.  Pain was so debilitating that I could barely walk, sit or stand.  Pain increased over time.  Pain in the sciatic nerve began on Friday, Nov 19 after the the vaccination was administered and has continued.  Also, soreness of right arm at injection and fatigue.
Increased temp one hr post vaccines-103 deg lasted 24 hrs. Vomited 3/5/04 increased sleep 3/5/04 fully recovered 3/6/04 evening.
Technician administered vaccine intramuscular into right deltoid. Vaccine dripped a large clear droplett down patients arm upon administration. It is likely vaccine leaked out of syringe. We were using pre drawn syringe so likely leur lock syringe was loose or faulty.  According to CDC Website dose could be repeated immediately or can wait 8 weeks for re administration due to risk of pericarditis. pt wanted to wait 8 weeks to re administer.
Prolonged soreness/pain complaints from site of injection diminishing over time but lasting 5 weeks. Complaints finally subsided 12/31/09.
Silver dollar sized raised bump, warm to the touch, hard and small blisters within red area.
had sot @ 130PM & about 8PM started getting sick for 3 days p/, vomit, sick to stomach;
pt recv 4MAR96 & 16MAR96 pt exp rash, sl fever, enlarged glands, aching body & scratchy throat;
This spontaneous report as received from a Nurse Practitioner (NP) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 09-AUG-2012 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscular. On 16-OCT-2012 the patient was vaccinated with the second dose of GARDASIL and on 16-NOV-2012 with the third dose. The third dose of GARDASIL was administered one month after the second dose. No adverse effects were reported. No further information was provided. Additional information is not expected.
Loose BM's in the evening of the vaccine and the next morning, turned to Diarrhea. Subsequently during that time, it was intermittent diarrhea. It was either very soft or very watery. I noticed I was having more shortness of breath that usual. It's common for me to have some shortness of breath but this was more. That went on for a month or so. I happened to see Pulmonary Dr because of my  normal appt.
Patient experienced what appeared to be a vasovagal event. regained consciousness within a few minutes. diaphoretic and expressed fatigue. Patient declined further evaluation by hospital staff. Observed for an extended amount of time until symptom free and patient departed.
This spontaneous case was reported by a nurse and describes the occurrence of LETHARGY (Lethargy after 2nd dose), VACCINATION SITE PAIN (Pain on the injection Site after 2nd dose), NAUSEA (Nausea after 2nd dose) and ACCIDENTAL OVERDOSE (Received 0.75 ml instead of 0.5 ml for 2nd dose / Received an overdose for 2nd dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .75 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 0.75 ml instead of 0.5 ml for 2nd dose / Received an overdose for 2nd dose). On 01-Feb-2022, the patient experienced LETHARGY (Lethargy after 2nd dose), VACCINATION SITE PAIN (Pain on the injection Site after 2nd dose) and NAUSEA (Nausea after 2nd dose). On 31-Jan-2022, ACCIDENTAL OVERDOSE (Received 0.75 ml instead of 0.5 ml for 2nd dose / Received an overdose for 2nd dose) had resolved. On 03-Feb-2022, LETHARGY (Lethargy after 2nd dose), VACCINATION SITE PAIN (Pain on the injection Site after 2nd dose) and NAUSEA (Nausea after 2nd dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. The reporter stated that the patient received a 2nd dose of 0.75 ml instead of 0.5 ml on 31-Jan-2022. The next day on 01-Feb-2022, the patient reported that they had Nausea, Lethargy, and Pain on the injection Site and on 03-Feb-2022, the patient was fine. The reporter also stated that they already reported to VAERS. No treatment information was provided.