chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that on 9/20/19 he came down with chills and fever (flu like symptoms) which subsided after 14 days. A week after that subsided he started getting extreme muscle spasms and nerve pain for 5 days in both arms. On 10/21/19 the nerve pain and muscle spasms spread to his legs/toes. He also reports numbness on top of head and has continued intermittent nerve pain since the vaccination date.
Pt reported pain night of immunization. Day 2 pt reported increasing pain and possible fever- pt presented to pharmacy on day 3 with area of redness and possible swelling, but symptoms appear to be improving.
put me down for 4 days feeling just awful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2022 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "no problem"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "no problem"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "no problem". The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "put me down for 4 days feeling just awful".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a physician refers to a 79 year old female patient. On 05-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J000494, expired date: April 2014). On 06-JUN-2013, the patient developed injection site reaction after receiving ZOSTAVAX. The physician mentioned the area was a 3 to 4 inch red oval, consistent with where the vaccine was administered. The patient had sought medical attention via office visit and was given treatment with ice. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
24-28 Hours after DTaP shot in right thigh, father noted redness and swelling approximately 5 inches. Took daughter to ER. This report may have been submitted by them: hospital ER.
GOT THE SHOT and  GOT THE SHINGLES/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got the shot and still got the shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Case number PHEH2012US020090 is an initial spontaneous report received from a pharmacist on 05 Oct 2012. This case refers to a 27-year-old male patient. He was vaccinated only with MenCYW-135 liquid conjugate component of MENVEO vaccine (batch number: X10053) intramuscularly on 05 Oct 2012. He did not receive the MenA lyophilized conjugate component of MENVEO vaccine. The pharmacist stated that they did not event intend to administer MENVEO and thought they were administering TDAP (other manufacturer, batch number: not reported). no other information was available.
pt recv vax 21JAN93 & 31JAN93 pt exp fever, fussiness, tiredness & had trouble walking;pt seen in MD office gait appeared nl;
LEFT NERVE PALSY IN EYE (LEFT); GIANT NERVE SYNDROME (LEFT EYE); DOUBLE VISION IN LEFT EYE; AT ONE POINT UNABLE TO SEE OUT HER LEFT EYE; BLURRY VISION IN BOTH EYES; INABILITY TO MOVE LEFT EYE; This spontaneous report received from a patient concerned a 62 year old African American and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient experienced inability to move left eye and double vision for 2.5 months and blurry vision in both. These started in AUG-2021 and lasted 2.5 months. At one point patient was unable to see out of her left eye at all. Consumer was constantly at Emergency room (ER) and saw ophthalmologists. They did a Magnetic resonance imaging (MRI) and Computerised tomogram (CAT) scan and it had to do with the nerve in her eye. On an unspecified date in SEP-2021, patient was told, she had left nerve palsy in eye(left) and giant nerve syndrome (left eye). Laboratory data (dates unspecified) included: Computerised tomogram (CAT) scan (NR: not provided) left nerve palsy in eye(left) and giant nerve syndrome (left eye), and Magnetic resonance imaging (MRI) (NR: not provided) left nerve palsy in eye(left) and giant nerve syndrome (left eye). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from at one point unable to see out her left eye, and inability to move left eye on NOV-2021, was recovering from blurry vision in both eyes, and double vision in left eye, and the outcome of left nerve palsy in eye (left) and giant nerve syndrome (left eye) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220122189-COVID-19 VACCINE AD26.COV2.S-Left nerve palsy in eye(left),At one point unable to see out her left eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Had shingrix two years ago/do i get second shot or start over; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Had shingrix two years ago/do i get second shot or start over). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 8-Aug-2023 The patient asked that he or she get second shot or start over. The centers for disease control and prevention (CDC) had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients did not need to restart the vaccine series. The follow-up could not be possible as no contact details were available. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Presented to Hospital on 9/10/21 having paresthesias for about a week.  Had been seen by PCP on 9/7/21 who suspected Guillain Barre.  Presthesias first started on toes and moved up towards knees, then appeared in fingers moving up towards his elbows,  He felt off balance and couldn't  walk as far as previously, and his grip felt weaker. Lumbar puncture and CSF fluid studies revealed elevated protein, consistent with Guillain Barre.   In the hospital, patient was treated with IVIG for 5 days beginning on 9/10/21, but he continued to have worsening symptoms.  Plasmapheresis was started 9/15/21 and scheduled for every other day for 5 treatments total.  Patient was also started on steroids 9/14/21 and is currently still tapering down.
She had a sore arm; At the third day she had problems breathing; She was very tired the next day,exhausted even; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a sore arm), DYSPNOEA (At the third day she had problems breathing) and FATIGUE (She was very tired the next day,exhausted even) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She had a sore arm), DYSPNOEA (At the third day she had problems breathing) and FATIGUE (She was very tired the next day,exhausted even). On 19-Dec-2021, DYSPNOEA (At the third day she had problems breathing) had resolved. At the time of the report, PAIN IN EXTREMITY (She had a sore arm) and FATIGUE (She was very tired the next day,exhausted even) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
Body aches all over, treatment was rest and outcome went away after 3 days. Exhaustion, treatment was rest and outcome went away after 6 days. Chest pain, treatment was rest and started day 2 and went away day 4. no treatment. Shortness of breath, treatment was rest, started day 2 and went away day 3. no treatment. Cough, chills and fever, congestion, temperature started day of shot and went away 4 days later, no treatment Rash near injection site, started day 2 went away day 5, no treatment. Temperature of 103, started 6 hours after shot and went back to normal day 5, took Tylenol to reduct temperature. Stomach craps started day 2 lasted about 6 hours. No treatment.
Patient in observation. Patient experienced syncope for approximately 10 seconds. Patient awakens. Patient vital signs BP-179/79 HR-76 T-98.6. When patient awaken,  AOx3 and she began drinking a bottle of water. Patient monitored. Patient husband and daughter in car. Patient monitored. Vital signs retaken BP-138/78 HR-64 R-16. Patient verbalizes feeling better and anxiety has decreased. Patient and family educated on worsen symptoms and when to seek medical attention.
Lightheadedness, shakiness, sweating upon onset of symptoms; elevated BP; nausea, headache, body aches throughout the day, low grade temperature in evening; onset of sore throat in pm & next am with worsening headache & continued body aches throughout the next day.
I reviewed safety report. Safety report included patient being seen in clinic and prescribed influenza vaccine however was administered Pneumovax instead. Patient and provider were both notified. No documentation of adverse events or symptoms.
Patient became short of breath immediately after administration. Face and chest became very red and she told me her chest was tight and she could not breath. Prior to vaccine administration, patient verbally told me as well as documented on the intake form she had gotten her flu shot most every year and had never had any sort of reaction to it.  When I saw that the patient was having trouble breathing, I immediately administered one dose (0.3 mg) of an epi pen to her thigh and told a nearby person to call 911. After epi pen administration patient's face coloring went back to normal and she was able to breath. Paramedics arrived shortly afterwards and took patient to the hospital to ensure she was alright.
Pain in upper left arm for several weeks. Gradually become more sore and moved into the shoulder area. Within the next 2 months, the pain in shoulder was excruciating. Could not raise my left arm, pain interrupted sleep. Went to orthopedic doctor who diagnosed it as "Frozen Shoulder"  Adhesive Capsulitis and gave me an injection of cortisone and suggested physical therapy. The exteme pain was helped by the injection but the range of motion did not improve until many more months of physical therapy and two more cortisone injections.  All told the duration was over a year and my range of motion of pretty much restored, but there is still some pain when stretching the shoulder joint.
12 05 PM: PATIENT LAY DOWN ON THE FLOOR, SAY HE FEEL DIZZI. SATURATION AT 100%, bp AT 101/61,hr 61/MIN. PATIENT LAY DOWN FLAT. EMS, SITE MANAGER, AND NP PRESENT.                                                                               12 11 PM: 106/59 ,SATURATION AT 100%, HR;81/MIN. PATIENT FEEL BETTER, PARENTS STATE THAT PATIENT HAD NO BREAKFAST THIS MORNING AND WENT TO SPORT PRACTICE BEFORE VACCINE.                                                                        12 14 PM: SEAT UPWRITH, PATIENT FEEL BETTER, DISCHARGE BY NURSE PRACTITIONAR.
One hr after admin of vaccines: onset. Nausea and dizziness, Left deltoid: redness, warmth, swelling, itchy, measuring 35mm 48 hrs later. Headache after 24 hrs.
Information has been received from a medical assistant concerning a female patient (date of birth unknown at time of report) with an extensive unspecified medical history, including allergic to flu shot in the past, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 663889/0632Y). Subsequently the patient had a very red arm after vaccination. The patient went to office for medical attention. At the time of the report, the patient was not recovered. It was reported that the patient sees an allergy specialist. The office requested a lot check. Information has been received indicating the 63 year old patient had experienced localized redness 9 days after vaccination with a dose of PNEUMOVAX 23. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Edema of upper eyelids; Itchy, red skin on face, neck, hands and left arm; Red skin on face, neck, hands and left arm; Hives on tops of hands and on neck.; Dose received: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 53-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 18:30 (Lot number: UNKNOWN) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Palsy Bells" (unspecified if ongoing), notes: Bells Palsy at age 23; "Iodine contrast media allergy" (unspecified if ongoing), notes: Possibly iodine (when used for imaging) and "Shellfish allergy" (unspecified if ongoing), notes: may have a sensitivity to shellfish. Concomitant medications included: VITAMIN D, MULTI-VITAMIN and NUTRAFOL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm), administration date: 14Apr2021, when the patient was 53 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical site: Left arm), administration date: 05May2021, when the patient was 53 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 18:30, outcome "unknown", described as "Dose received: 3"; EYELID OEDEMA (non-serious) with onset 30Nov2021 at 16:30, outcome "not recovered", described as "Edema of upper eyelids"; PRURITUS (non-serious) with onset 30Nov2021 at 16:30, outcome "not recovered", described as "Itchy, red skin on face, neck, hands and left arm"; ERYTHEMA (non-serious) with onset 30Nov2021 at 16:30, outcome "not recovered", described as "Red skin on face, neck, hands and left arm"; URTICARIA (non-serious) with onset 30Nov2021 at 16:30, outcome "not recovered", described as "Hives on tops of hands and on neck". Therapeutic measures were not taken as a result of eyelid oedema, pruritus, erythema and urticaria.  Additional Information: 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Symptoms developed 22 hours after booster shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
PATIENT WAS GIVEN A 65+ VACCINE AND HE IS ONLY 2 - WATCHED FOR 20 MINUTES AFTER VACCINE WAS GIVEN AND CONTACTED HEATLH DEPARTMENT - ADVISED MOTHER TO WATCH FOR SWELLING / PAIN / REDNESS - WILL FOLLOW UP WITH MOTHER ON 10.8.19 TO SEE HOW PATIENT IS DOING
This case was reported by a other health professional via other manufacturer and described the occurrence of allergic edema in a 53-year-old female patient who received DTPA vaccine. Co-suspect products included AUGMENTIN unknown for an unknown indication, PHENERGAN for an unknown indication and VIOXX for an unknown indication. Previously administered products included Aspirin (81 mg EC tablet orally daily), CYMBALTA (60 mg capsules orally two times daily), NORCO(10-325 mg per tablet orally every 6 hours as needed for pain), LAMICTAL (200 mg tablet orally twice ad ay) and PRILOSEC (40 mg capsule orally). Concurrent medical conditions included anxiety. Concomitant products included XANAX. On an unknown date, the patient received DTAP vaccine at an unknown dose, AUGMENTIN at an unknown dose and frequency, PHENERGAN at an unknown dose and frequency and VIOXX at an unknown dose and frequency. On an unknown date, an unknown time after receiving DTAP vaccine, AUGMENTIN and PHENERGAN, the patient experienced allergic edema and redness. The action taken with AUGMENTIN was unknown. The action taken with PHENERGAN was unknown. The action taken with VIOXX was unknown. On an unknown date, the outcome of the allergic edema and redness were unknown. It was unknown if the reporter considered the allergic edema and redness to be related to DTAP vaccine and AUGMENTIN. Additional details provided were as follows: On 3rd November 2011, it was reported that, the patient had experienced allergic reactions as swelling and redness after she received AUGMENTI, PHENERGAN and VIOXX (exact start dates of drug administration and event onset were not provided). On 7th November 2011, similar reactions were noted after receiving DTAP vaccine (exact start dates of vaccination and event onset were not provided). On 19th May 2015, the patient started MIRAPEX (0.25 mg tablet) one tablet by mouth in night as needed. On 19th May 2015, the patient also started ZOCOR (20 mg tablet) one tablet by mouth in night. This medication was prescribed to be stopped on 18th May 2016. On 5th October 2015, the patient started NICOTROL inhaler (10 mg per ml) one spray in each nostril 1 to 5 times per hour for 8 weeks maximum was 80 sprays.
my arm hurt; I was hallucinating; my body was convulsing/having a literal seizure; uncomfortable; thirsty and craved water; tired; couldn't get up; felt freezing because I was so cold; teeth were chattering extremely fast; my teeth were chattering extremely fast like I had hypothermia; became very hot; shaking involuntary; This is a spontaneous report from non-contactable consumer (patient). An adult female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on Apr2021 (Batch/Lot Number: EW0110) as second dose, single for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin; spironolactone; ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE); all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. Patient historically took the first dose of BNT162B2 (lot number: EW0150) on the left arm on Apr2021 for COVID-19 Immunization. On 27Apr2021, patient went to bed at like 1200 and her arm hurt but she didn't take any medication. Then, patient like woke at about 1:47 and was shaking involuntary, everything was so uncomfortable and she was hallucinating trying to connect all her limbs - like she grew extra arms and legs and she had like her hands had mini hands and a friend that she hadn't seen in a while (who was not there) was holding her head up. She was very thirsty and craved water so bad but she was so tired and shaking that she couldn't get up. After about 30 minutes, she got up and her body was convulsing while standing and her room which is typically warm felt freezing because she was so cold and her teeth were chattering extremely fast like she had hypothermia. She got water, took some ibuprofen and she got back in her bed. she texted a friend at  2 something in the morning because she thought she was having a literal seizure like she couldn't control her body at all. Then, her body eventually stopped shaking on Apr2021 and she was just above sleep level for another hour or two and then became very hot. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included covid-19: negative on Apr2021. The outcome of the event 'having a literal seizure' and 'shaking involuntary' was recovered on Apr2021, while for the other events, it was unknown.  No follow-up attempts are possible. No further information is expected.
Patient was administered a third dose after completing 2 dose series of HPV in 7/2019.
Initial report received from a patient on 29 August 2007. A 29 year old, male patient (with no medical history) developed a stuffy nose, sore throat and swollen glands in the neck, a few hours after receiving his fourth dose of IMOVAX (lot number A0208-2) intramuscularly in the right arm on 28 August 2007. He had a bat bit in April. He received the following previous vaccines: IMOVAX - dose 1 and IMOGAN - dose 1 on 14 August 2007; IMOVAX - dose 2 - intramuscularly on 17 August 2007; IMOVAX - dose 3 - intramuscularly on 21 August 2007. There were no adverse reactions reported after the vaccinations. At the time of the report, the symptoms were resolving. Follow-up information received on 12 October 2007 from a health care professional. The case was reviewed, and there was no additional information.
Day #5, woke up with rash like symptoms on back of arms and on back and front of upper legs. Thought I was breaking out in hives but did not breakout. Symptoms is like breaking out. Took antihistamine to control somewhat.
Redness at inj. site silver dollar size, shoulder and neck pain for one week with tingling on left side of face Date of Onset: 1/5/2021 Patient took tylenol.  No follow-up with any healthcare provider
Patient came to clinic for 1st Monopox vaccine. Vaccine given IM instead of Subq route. Patient was then contacted and updated. Patient denied any reaction to vaccine.