chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second Shot - Left arm completely numb, sore, and unable to move for 24 hours, pain diminished after 72 hours.; Second Shot - Left arm completely numb, sore, and unable to move for 24 hours, pain diminished after 72 hours.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 10:00 (Lot number: em9009) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACCUTANE. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: el8982, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 21Jan2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "Second Shot - Left arm completely numb, sore, and unable to move for 24 hours, pain diminished after 72 hours.".  Additional Information: If other vaccine in four weeks was reported as no. If covid prior vaccination was reported as no. If covid tested post vaccination was reported as no. No Known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101796094 similar report from same reporter
Besides the usual fever, chills, malaise, body aches and fatigue, I had pain behind my left eye. It felt like a "headache" behind my left eye and it hurt when I moved my eyeball up, down or side-to-side.
Morning after vaccination, noticed stiffness to entire body.  Felt weak and stiffness/weakness did not resolve and increased in nature.  Was seen by private physician and then referred to ER. Admission diagnosis of Myalgia & Myoclonus.
c/o rash started on head, neck, arm dec energy & itching; no definite fever; same batch as last react; DPH if needed;
she knows of people who have received a mix of the Pfizer and Moderna vaccines; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (she knows of people who have received a mix of the Pfizer and Moderna vaccines) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown.
administrated /an expired dose/on June 29 2021/ expired on May 30 2021.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa (Infanrix) (batch number j947t, expiry date 30th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received 1st four doses, on an unknown date).   On 29th June 2021, the patient received the 5th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 29th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The nurse reported that, the patient received dose of Infanrix  which was expired on 30th May 2021, which led to expired vaccine used. No adverse event was reported. The vaccine was provided on another facility.  The reporter did not consent to follow-up.
Information has been received on 11/20/2001 from a physician concerning an 8 year old male who "over a year ago" was vaccinated with a dose of varicella vaccine. It was reported that the pt "breaks out in a chicken pox type rash about every 6 months." After the second break out, antibody tests showed that the pt was IgG positive and IgM negative. Six months later, the pt "breaks out a third time." The pt was given another antibody test and was found to be IgG positive; however, the IgM results were "not back yet." The pt sought unspecified medical attention. Follow-up info from a woman in a physician's office and a physician noted that the four year old male was vaccinated on 06/10/1997 with one dose of varicella vaccine. There was no illness at the time of vacciantion. In November 1997, the pt developed a vesicular rash. Since, November 1997, the pt has had intermittent breakouts of this vesicular rash which occurred in September 1999 approximately 05/14/2001 and approximately 11/14/2001. On 11/14/2001, a skin biopsy revealed :there is ulceration accompanied by cells whose nuclei are steel gray with margination of nucleoplasm and multicucleate epithelial cells. The diagnosis from the skin biopsy was herpes virus infection. VZV AB IGG and IGM tests done on 05/14/2001 were 1.74 ISR and 0.12 ISR, respectively. VZV AB IGG and IGM tests done on 11/17/2001 were 6.11 ISR and 4.38 ISR, respectively. It was noted that the pt recovered three days later. No further info is expected.
died; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient who was completely healthy died on an unspecified date. Reporter stated that she had "great concerns about the Pfizer COVID 19 vaccine and actually all three of the vaccines on the market. She had been so distraught over the last couple of weeks since she found out that they are wanting to start experimentations on babies and that the babies can not handle this. She wanted to ask someone how does this fit in with the Nuremberg code since the babies have no awareness of what is going on since they are 6 months or less? She stated experiments should be based on animal experimentation but by the way all the companies skip animal testing. 15 years ago all the animals tested for the coronavirus vaccine died. The 30 year old mother that died bothered her completely and she never even met that person. The reporter stated people should have survived and that people do not need vaccine junk science and that it is making them into some operating system. She stated the vaccine is not helping and this was created just to create more fear." It was not reported if an autopsy was performed.  Information about lot/batch number has been requested.  ; Reported Cause(s) of Death: Died
Heathcare professional or Clinic Site: After approximately eight hours after the shot, I woke up with SEVERE; chills, fever( hallucinating), headache, body aches- could not hold myself upright, sever nausea and stomach pains, vomiting for eight consecutive hours.  For the next 48 hours, I felt spacey, couldn't remember words, could not go to work, very fatigued.
When medical assistant was removing sticker from shingrix vial, it was discovered the vial was broken. PCP and onsite LVN were notified immediately when incident occurred.
SWELLING OF BOTH EYELIDS- UPPER AND CORNER; SWELLING OF LEFT SIDE OF FACE; HEADACHE BEHIND EYES; DIZZINESS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included dust allergy, allergy to cats, antibiotic allergy (hives), diverticulitis, alcohol intolerance, and drug intolerance. The patient was previously treated with calcium for hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802025, and batch number: 1802025 expiry: 25-MAY-2021) .5 ml, administered on 08-MAR-2021 09:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced swelling of both eyelids- upper and corner. On 09-MAR-2021, the subject experienced swelling of left side of face. On 09-MAR-2021, the subject experienced headache behind eyes. On 09-MAR-2021, the subject experienced dizziness. Treatment medications included: achillea millefolium/aconitum napellus/arnica montana root/atropa belladonna/baptisia tinctoria/bellis perennis/calendula officinalis/echinacea spp./hamamelis virginiana/hypericum perforatum/matricaria recutita/ruta graveolens/symphytum officinale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 09-MAR-2021, was recovering from swelling of both eyelids- upper and corner, and headache behind eyes, and had not recovered from swelling of left side of face. This report was non-serious.
Patient came to clinic today and presented with a possible reaction to the flu vaccine. The flu shot was administered on October 9, 2008. The patient had a quarter sized, red, swollen area on right upper arm at site of injection. Patient stated that her arm had been like this since she recieved her flu shot in October.
left arm immediately began swelling after administration of vaccine. Site red, swollen, warm to touch. Given oral Benadryl. Monitored in office for 30 minutes.
PATIENT RECEIVED FULL DOSE OF PFIZER BIVALENT, SHE CAME BACK THE NEXT DAY AND CLAIMED THAT WHEN SHE GOT HOME THE BANDAGE WAS SOAKED WITH LIQUID THAT DID NOT LOOK LIKE BLOOD, SHE DID NOT GET ANY SORENESS LIKE SHE WOULD WITH THE PREVIOUS COVID VACCINES. SHE WAS CONCERNED SHE DID NOT GET ALL THE VACCINE, DUE TO UNKNOWN AMOUNT OF VACCINE THAT LEAKED OUT, GUIDELINES RECOMMENDS REPEATING DOSE. SHE WAS INFORMED AND SAID SHE WILL COME BACK THE NEXT DAY TO GET REVACCINATED.
COVID-19/ Rebound of Covid symptoms and positive test result after testing negative 5 days after stopping treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19/ Rebound of Covid symptoms and positive test result after testing negative 5 days after stopping treatment) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, RA and Drug allergy (Unknown drug). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-May-2022 to 01-Jun-2022 for an unknown indication.    On 29-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19/ Rebound of Covid symptoms and positive test result after testing negative 5 days after stopping treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19/ Rebound of Covid symptoms and positive test result after testing negative 5 days after stopping treatment) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive after testing negative 5 days after stopping treatment.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. Device Date: 01-Jun-2022  Company comment: This case concerns a 46-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the fourth dose of mRNA-1273. Patient received NIRMATRELVIR, RITONAVIR as treatment which resulted in a positive COVID-19 test 5 days after testing negative with new onset of COVID-19 symptoms. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 46-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the fourth dose of mRNA-1273. Patient received NIRMATRELVIR, RITONAVIR as treatment which resulted in a positive COVID-19 test 5 days after testing negative with new onset of COVID-19 symptoms. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Woke up ~12 days later with chronic hives, rash, face flushing, joint paint, angiodema, head aches, dizziness, and trouble/pain when breathing. Went to ER twice on the basis that it was an allergic reaction. Was given prednisone, benadryl, and then eventually epinephrine. All helped a little bit for a short while, but after a day, symptoms returned.  Doctor has recently put me back on prednisone (80 mg), with symptoms persisting.
No Adverse Event; Received an expired monovalent vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired monovalent vaccine as a second dose) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired monovalent vaccine as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired monovalent vaccine as a second dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received an expired monovalent vaccine as a second dose).    No concomitant medications was reported. Vial size was 10 dose vial. Date the vial was initially stored in the refrigerator was 22-Sep-2022. Date of administration of vaccine was 19-Oct-2022. The vial didn't undergo any temperature excursions. No treatment drug details was reported.
Pt exp sx similar to pts who were dx w/fibromyalgia; details of these sx @ time of report were unk; No further details were provided;
arm has been really sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ARTHRALGIA. At the time of the report, ARTHRALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Infection on her toe nails.; Ask if she can take Doxycycline Antibiotic that her doctor prescribed for the infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAIL INFECTION (non-serious), outcome "unknown", described as "Infection on her toe nails."; POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Ask if she can take Doxycycline Antibiotic that her doctor prescribed for the infection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever; Chills; Body aches; Swelling at injection sight; Redness at injection sight; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left  arm on 24Apr2021 at 17:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 03Apr2021 at 18:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 16:00, the patient experienced fever, chills, body aches, redness and swelling at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, redness and swelling at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
In the first 36 hours site of injection very sore, red, and swollen. Noticed 8 days after vaccine that at the injection site a 3 inch by 3 inch area is red, swollen, hard if you touch area, warm, and a little itchy. No pain.  NO other symptoms have occurred.
Shaking; Chills; General malaise; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 58-year-old male patient received bnt162b2 (BNT162B2), administration date an unknown date in 2021 (Lot number: unknown) at the age of 58 years as dose 3 (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, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received: 3"; TREMOR (non-serious) with onset 16Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Shaking"; CHILLS (non-serious) with onset 16Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; MALAISE (non-serious) with onset 16Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "General malaise". Therapeutic measures were not taken as a result of tremor, chills and malaise.  Additional Information: It was unknown whether the patient received any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Extreme fatigue Nausea Problems with balance, walking Dizziness Blurry vision Slurred speech
Wrist bone is swollen on the right arm where she received  vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 29Jan2021 16:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 29Jan2021 19:00, the patient experienced that wrist bone was swollen on the right arm where she received vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 14Dec2020. No therapeutic measure was taken as a result of the events. Clinical outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4/24/21  1:05pm first dose Pfizer vaccine  1:10pm huge allergic reaction, felt like pre-anaphylaxis, like I was going to die  1:13pm took 2 Benadryl 25mg  5:30pm took 1 Benadryl 25 mg Loose stools all day, stayed home as Benadryl was working 4/25/21  12:30am took 1 Benadryl 25mg (weird feeling in my tongue)  1:25pm took 1 Benadryl 25mg for pain in my cheekbones & teeth and rash on both cheeks below eyes  1:58pm took 1 Benadryl 25mg   "    " 2:19pm took 1 Benadryl 25mg   "    " 2:49pm checked into hospital emergency room as allergic reaction would not subside 4:30pm got IV with Benadryl 25mg, Methylprednisolone & Pepcid (throat felt strange) 7:26pm discharged from ER 4/26/21 Medrol 24g 4/27 Medrol 20g