chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per patient, COVID shot on 5/1/21 was given too high and felt as if he were ?stabbed?. He states he has developed SIRVA per his doctor. He states he can not even lift his arm to change the blinker
on day of vax devel fever w/in 12hr (up to 103R) fever cont & arm became very swollen & red (7-10cm area, indurated, tender);
PNEUMOVAX 23 OUTDATED (EXP 1/28/22)
Pt was given first shot of Pfizer Covid 19 shot. Pt was instructed to stay 15 minutes for observation, After 10 minutes, pt had a seizure that lasted approximately 10 seconds. 911 was called . Pt was evaluated and taken to hospital and was discharged the same day. Follow up was done the next day via phone call. Pt stated she was fine
Pt has had a rash for 2 days - noticed on (R) leg - went to ER and BACTRIM for prescription did not take. Took Aspirin 8/25/13 - Rash is red. Rash where vaccine given 1.5 cm centered by 3 cm.
Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 16-FEB-2023 Reporter's Comment: The reporter was a healthcare professional. The reporter reported that the patient received Havrix vaccine that had been in a below temperature excursion and was not considered stable and it was administered to the patient. The reporter stated that the vaccine below temperature excursion was happened in October. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The Havrix vaccine temperature was exposed below temperature excursion, which led to incorrect storage of vaccine. This case was 1 of 6 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023026692:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026693:Same reporter US-GSK-US2023026694:Same reporter
The day after vaccination, the pt woke up with a two inch diameter lump in the injection site area. The pt experienced itching and was nauseated the entire day. The nausea resolved by the next evening and the itching continued for the 2 or 3 days post vaccination. The pt is recovered and did not experience any other symptoms or rxn's.
7/19/04: Late evening started with fever. Mother did not take the child's temperature but said the child felt warm and the child stated that he did not feel good. 7/20/04: Tuesday morning, child woke up with a temp of 103 and a terrible headache and was tired. Child cried. Mother gave child Tylenol. The fever stayed at 103 until the afternoon. Then the mother started Motrin and the temp dropped to 101. Mother also put the child in a bathtub of cool water to drop the temp. 7/21/04: Wednesday no improvement, child cried off and on all day, temp was 101, and he was very tired. Not enough energy to sit up. States he had no appetite or nourishment other than apple juice and other liquids for three days. Headaches continued. 7/22/04: Thursday, child was up a couple of times during the night. She gave him Motrin a couple of times. In the morning he woke up with a temp of 103. She called the clinic and they said to bring him right in . A midlevel practitioner examined the child. Child was still tired and complained of a stomachache. Mother states practitioner said this was due to the MMR shot. Exam revealed nothing unusual. No blood or lab work was performed. Practitioner advised the mother to give Motrin every 8 hours and give Tylenol every four hours between the Motrin, and soak him in a tub of cool water and return in 1-2 days if he was not better. 7/23/04. Friday, child had a pretty good night. However when mom got home form work on Friday evening, he was still sick and running a temp. She called the clinic and they were closing. About 8pm child started crying and cried until 10.30pm and she felt his fever was going back up so she took him to the ER. Temp in the ER was 102. Lab and x-ray were negative. There was no bacterial infection. Doctor's diagnosis was it was an acute viral infection. Mother was also told he had a heart murmur and she was never told that before. The left the ER at 4am. 7/24/04: Saturday, child slept until 11:00 am. Temp was up and down. Mother gave child Motrin 2-3 times during the day. He complained about being tired and had no appetite. 7/25/04: Sunday, mother states he was okay but had no appetite but was drinking fluids. 7/27/04. Tuesday: mother took child to doctor b/c one of his ears was starting to hurt. He was diagnosed with an ear infection and is now on antibiotics. Mother states doctor also feel the episode was due to the MMR vaccine.
2/1/2021: Awoke at 0500 and 0700 drenched in sweat. Muscle spasms started at this time (strong spasms all over body). Heart rate in 90s at rest (my baseline resting heart rate is 60) and up to 130s/140s with minor activity. Shortness of breath with activity.   2/2/2021: Insomnia overnight. More sweating. Strong muscle spasms continue all over body. Heart rate still in 90s at rest. Reported to ER for palpitations. Heart rate at 144 upon checking in. BP and oxygen levels normal.
sweating; fever; leg fatigue or tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PYREXIA (fever) and FATIGUE (leg fatigue or tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever) and FATIGUE (leg fatigue or tired). At the time of the report, HYPERHIDROSIS (sweating), PYREXIA (fever) and FATIGUE (leg fatigue or tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were provided.   Reporter did not allow further contact
I administered the vaccine Gardasil in (L) arm IM pt was ok at this point within 1 min after vaccine was administered pt. started getting dizzy, turned very pale and fell over to (R) side, her body then started shaking almost like a seizure, Dr enter the room pt was coming to herself we gave her a drink of soda her pulse Ox was 99% and she started feeling better.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 05Apr2021 at 14:30 as dose 1, single (Lot number: Ew0158), in left arm, on 10May2021 at 14:00 as dose 2, single (Lot number: Ew01262), in left arm and on 28Feb2022 at 14:30 as dose 3 (booster) single (Lot number: 011-476), in left arm for covid-19 immunisation. The patient's relevant medical history included: "BREAST CANCER DCIS HER2NEU+ ESTROGEN RECEPTORS" (unspecified if ongoing), notes: BREAST CANCER DCIS HER2NEU+ ESTROGEN RECEPTORS; "Animal allergy" (unspecified if ongoing), notes: Shrimp Crab Lobster. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 06Sep2023 to 10Sep2023.
4/20 vaccination 4/28 Started bleeding, cramping 4/29 persistent cramping, bleeding. I went to the ER and had had blood work done the day before positive 4.5 -5 weeks pregnant.  *CHEMICAL MISCARRIAGE
Suspected Vaccination failure; 1st thing I thought of was shingles / What are the possibilities that this could be shingles?; Hand size burning sensation near my lower ribs / Burning right lower ribs on torso; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient had chicken pox. The patient woke up this morning with a hand size burning sensation near my lower ribs on the right side lower ribs on torso. The patient thought of it was shingles. The patient asked what were the possibilities that this could be shingles? This case should be considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
It?s been 12 days and for the past 9 days I?ve had a red, warm, dense, itchy, painful lump at my injection site that is about 2 inches in diameter. It is mostly round with what looks like a 2 inch wide paintbrush stroke coming off of the side of it that wraps around my arm towards my body to my under arm. The swelling, warmth and firmness has gone down slightly over the past few days. I put triamcinolone on it and it reduced the symptoms slightly.
Swollen/painful lymph node in left groin - started day 3 (4/16), lasted 10 days, still 10% swollen/no pain as of day 22 (5/5). Rash (mild/light pink) around left groin lymph node, creates a semi-circle perimeter 4 inch radius from lymph node - started day 10 (4/23), still persists as of day 22 (5/5)
Pt experienced an area at the injection site which was swollen, red and hot to the touch, the same evening as receiving vaccination. The afflicted area was the size of a tennis ball. The arm was very sore and felt extremely heavy. The swelling lasted for 5 days but symptoms decreased daily. The stiffness lasted for 2-3 days. Pt states she received an influenza vax in 1998 without incident.
taste and smell went away; taste and smell went away; Feeling bad; Nasal congestion; had a cold; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a 32-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 (at the age of 32-years-old) (Lot Number: EW0164; Expiration Date: Aug2021, NDC number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. There were no patient medical history and concomitant medications. No adverse event following prior vaccinations. Patient previously took first dose of bnt162b2 (Lot number: ER8732; Expiration Date: Jul2021) administered in right arm on 10Apr2021 (at age of 32-year-old) for covid-19 immunisation. The patient was feeling bad on Thursday 09Sep2021. To clarified feeling bad he had no fever, no body chills, and no aches. He only had nasal congestion. That lasted from ninth, tenth, eleventh, and twelfth. On 13Sep2021, his taste and smell went away. That only lasted until 15Sep2021. Everything came back on 15Sep2021. He only had nasal congestion, no cough. His taste completely went away on 13Sep2021 and by 15Sep2021 he was able to smell and taste again. The patient had a cold on an unspecified date in Sep2021. None of additional vaccines administered on same date of the Pfizer Suspect. Patient did not require Emergency Room and Physician Office for the events. The patient underwent lab tests and procedures which included COVID test: unknown results (he is awaiting the results) on an unspecified date in 2021. It was reported that he valued human life. He was doing his part to protect himself and make sure he was not infecting other people in case he gets it. There were a lot of people that are immune suppressed. There were kids out there and old people who could be sick at any point and time by touching a countertop. Outcome of event Nasal congestion was recovered on 12Sep2021. Outcome of events feeling bad and had a cold were unknown while taste and smell went away were recovered on 15Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101244374 same reporter/product, different patient / event.
Patient received anthrax and JEV on 08/27/2008.  Before immunizations were given, patient was asked could you be pregnant.  Patient stated no per HN.  On 09/05/2008, patient had a positive pregnancy test and is currently 6 weeks pregnant.  At the time the immunizations were given, the pt was 4 weeks and 5 days pregnant.  Patient and MO are aware of the situation.
No further AE details; dose of expired PNEUMOVAX 23 was given to a patient; This spontaneous report was received from a medical assistant and refers to an unknown patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-SEP-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5ml/once, lot #U032086, expiration date: 29-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). It was reported that product has had no previous temperature excursions (TEs).  There were no adverse events reported (no adverse event).  This is a non-valid report due to lack of patient's identifiers.
Day 9 pt began low grade fever off and on for about 18 hours. Temp up to 101.4 axillary at times giving TYLENOL approximately every 4-6 hours. At 7pm began febrile seizure lasting approximately 3 minutes requiring transport by EMS to nearest emergency room, oral suction while in transport. Temp when arrived ER was 105.4. Released 3 hours later after monitoring for further effects.
Feeling tiredness/unwell; Feeling tiredness/unwell; Arm pain/soreness at injection site (expected); Arm pain/soreness at injection site (expected); This is a spontaneous report from a contactable nurse, who is also the patient. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 21Dec2020 at 10:30 at single dose for COVID-19 immunisation. Vaccination facility type was hospital. The patient had no relevant medical history. Concomitant medications were not reported. On 22Dec2020, the patient experienced feeling tiredness/unwell and arm pain/soreness at injection site (expected). The patient did not receive corrective treatments. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination she has not  been tested for COVID-19. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
Patient experienced syncope and dizziness while at the observation area (about 5-6 mins after the vaccination). Per patient and her family, she only had a piece of seaweed and water for breakfast.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site). At the time of the report, VACCINATION SITE RASH (Rash around the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact  Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: NNI
He has s had severe pain in left shoulder that radiates pain up into his neck, causing some headaches and seeing black spots. He cannot put his arm behind him, raise it up very high, and interferes with everyday living which is causing a lot of frustration and depression! It's been about 5 weeks and has taken Advil & Tylenol with no relief; feels the same pain & lack of mobility each day with no improvement.
The MRI shows an adhesive capsulitis with a degree of synovitis.  Severe pain with limited range of motion of the  left shoulder. I am unable to dress, shower and tie my hair by myself. I have had to stop all physical activity and i am unable to sleep comfortably without waking up at night with the pain.
This spontaneous report was received from a registered nurse refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M017334, 05-OCT-2017. No adverse effects were reported. This is one of the several cases received from the same reporter. Additional information has been requested.
Vaccine rec'd 3/23 - 3 hours later I had fever and chills, it went away and it came back 3 days in a row, then I started having leg cramps and on 3/26 I had anus bleeding of almost 1/2 cup.
left arm paralyzed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MONOPLEGIA (disability, medically significant), outcome "unknown", described as "left arm paralyzed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had chills; Fever; Couldn't sleep at all last night; Dry mouth; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a day after receiving Shingles vaccine, the patient experienced chills, fever, insomnia and dry mouth. On an unknown date, the outcome of the chills, fever, insomnia and dry mouth were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, insomnia and dry mouth to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported.       The patient received 1st dose of Shingles vaccine one day before reporting and had chills, fever and could not sleep at all last night. Less than a week after vaccination, the patient experienced a dry mouth. The patient stated that hopefully he/she would feel better on 19th March 2022. Follow-up could not possible as no contact details were available
Site of injection is red, swollen (size of 3-4 cm), hard and painful.
This case was reported by a physician to a vaccine distributor and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  Information regarding previous immunization with influenza virus vaccine was not provided.  On an unspecified date on or before 14 November 2007, the subject received unspecified dose of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, the subject experienced rash.  At the time of reporting the outcome of the event was unspecified.
Received Hepatitis A and Varivax vaccines.  Developed 2 urticaria lesion on face and urticaria abscess 1/2 hour later then urticaria progressed.
This spontaneous report as received from certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot # N003194, expiration date 28-OCT-2017) (dose and route were not reported). The vaccine was exposed from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 15 minutes. Also there was previous temperature excursion from 32 Fahrenheit (°F) degrees to 35 Fahrenheit (°F) degrees for 19 hours and 30 minutes and from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 1 hour and 45 minutes. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA010094: US-009507513-1709USA009372.
Left side of left arm became numb, down side of arm and three fingers. Left side of left leg also felt numb but half as much as the arm.  No treatment. It went away by 10 am the next morning.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 12May2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jul2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Dec2021 at 12:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal Allergies" (unspecified if ongoing), notes: Seasonal allergies. The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin", notes: Known allergies: Clindamycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient had not taken any other medications within 2 weeks of starting COVID-19 treatment. Took Paxlovid, felt great. 5 days later, began to have some minor upper respiratory symptoms such as nasal congestion, tested positive for COVID-19 via an antigen rapid test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Two weeks after varicella vaccine was given client had a red area at site of shot measuring 23mm by 43mm. It was tender to touch and itched around site. The next day she broke out all over. She was seen at clinic and told she had chicken pox.
nausea, severe regurgitation, cold sweats, fever, flushed, chills;