chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient is still experiencing extreme joint pain, fever, head congestion, lethargy. Patients arm that was injected has a big red welt and is swollen. Said arm feels heavy and hard to lift up..
pediarix was administered to a 14 yr old; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number j953n, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 pediarix dose was administered to a 14 years old patient, which led to inappropriate age at vaccine administration. No vaccination history was available for the patient. The reporter consented to follow up. This case has been linked to US2021223565, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223565:same reporter
Extreme pain in right arm at inj. site within 2 hours. Became very weak, shivers, chills, sweats, unable to sleep. Sore muscles & joints, no energy. Uncontrollable sugar which has stayed just over 200.
This spontaneous report was received from a physician regarding a male patient of unknown age with atrial fibrillation and with no drug reactions or allergies. On an unknown date (reported as "on a Friday") the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported) (dose, route and anatomical location not reported). No other suspect therapies were reported. Concomitant medications included warfarin (manufacturer unknown). The patient returned to the physician's office on an unknown date (reported as "the following Tuesday") with a significant varicella-like rash. The rash was present on the patient's trunk area and both axillary and post-axillary areas on the same side. The outcome for varicella-like rash was unknown at the time of the report. The patient was prescribed with VALTREX and gabapentin to treat his symptoms. No laboratory diagnostic studies were performed. The physician did not assess the causality between ZOSTAVAX and varicella-like rash. A VZVID packet was sent. Additional information has been requested.
Hives on arms , legs , torsos; Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on arms , legs , torsos) and RASH (Rash) 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives on arms , legs , torsos) and RASH (Rash). At the time of the report, URTICARIA (Hives on arms , legs , torsos) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
2 1/2 x 3 cm reddened area surrounding site of injection of varicella vaccine given 02/23/2006.
This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8735), at the age of 46, via an unspecified route of administration, right arm, on Apr 14, 2021, at 10:30, single dose, for COVID-19 immunisation. Medical history included COVID-19. Patient has no known allergies. Prior to the vaccination, patient diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not receive any other medications within two weeks of vaccination. On Apr 16, 2021, at 06:00, patient experienced vertigo (dizziness). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of vertigo (dizziness): not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Left deltoid cellulitis  ( erythema, edema,  hard and hot touch , size 6x7 cm)
About 40 minutes post vaccines mom noticed a raised, fine, red, papular rash on left leg. Upon observing leg had a few other sports on right leg and 1 spot on right arm. And a few spots on belly and back. Denies trouble breathing. Patient nursing from mother after vaccines. Mucous membranes intact, no change in behavior, no itching or bother to patient.
Increase swelling thigh - 10 cm swelling to (L) thigh - 20 cm swelling to (R) thigh - BENADRYL susp. 3/4 tsp PO - SOLUMEDROL 0.38cc IM
Ovarian insufficiency.  LMP was 1/6/2021 and no menstrual periods since vaccine; Laboratory studies obtained 4/9/21 showed estradiol < 20 (undetected), FSH and LH in menopause range, normal prolactin level; Repeat labs 2 weeks later were increased estradiol level, with continued menopausal levels. Pt started on Hormone replacement therapy, took 5 days and started menses and stopped HRT, evaluation is ongoing with GYN and follow up planned 5/13/2021
shoulder and neck pain; discomfort; shoulder and neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (shoulder and neck pain), DISCOMFORT (discomfort) and ARTHRALGIA (shoulder and neck pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (shoulder and neck pain), DISCOMFORT (discomfort) and ARTHRALGIA (shoulder and neck pain). At the time of the report, NECK PAIN (shoulder and neck pain), DISCOMFORT (discomfort) and ARTHRALGIA (shoulder and neck pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Experienced a headache that has not went away. She is very fatigue, chills, enlarged lymph nodes behind her ears and under armpits, dizzy spells, sensitive to light.
4hr p/vax pt became pale, clammy, hypotonic & hyporesponsive, had no fever;
Started at 8:45am with administrator hitting my bone with the 1.5" needle she was using (I am 125 lbs) and caused me to bleed. By 12pm my arm was swollen, red and hurt to move. That evening I woke up and vomited, had a fever of 100.6 and my body hurt like I had the flu. I slept all day Saturday and Sunday I woke up, my body pain was gone but my arm was red and swollen. Monday I went to work and had the APRN look at it as the redness was to my elbow and she diagnosed me with Cellulitis and treated me with 10 days of Doxycycline.
1055 pt received vaccination.   1110 and stated she "felt a little off". pt denied difficulty breathing and waited another 10 min at site. 1120 pt stated feeling her throat was tightening and dizziness. pt was placed on a gurney. vitals retrieved. HR 117 BP 150/90 RR 24 O2 99%. was put on 5L O2 via face mask. lip swelling confirmed and EMS alerted.  1121 IM dose of Epinephrine 0.3ml administer.  1125 EMS arrived on scene. O2 99% HR 113 BP 140/90 RR 20.  1128 pt transported off site by EMS to ED
Pain under injection arm; Fever/shivering; Fever/Shivering; Nausea; Headache; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 02Feb2021 at 16:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypercholesterolemia and seasonal 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 COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), simvastatin (SIMVASTIN), colecalciferol (VITAMIN D3), calcium (MANUFACTURER UNKNOWN) and mult (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the left arm on 13Jan2021 at 15:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 04Feb2021 at 06:00, the patient experienced pain under injection arm, fever/shivering, nausea, headache and muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures not 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 pain under injection arm, fever/shivering, nausea, headache and muscle aches were recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
redness at injection site/band around arm; warm to touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 24th November 2020) for prophylaxis.   On 29th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and skin warm. On an unknown date, the outcome of the injection site erythema and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient developed redness at the injection site and a band around her arm that was warm to the touch.  At the time of reporting, this event was ongoing. The reported batch number for Shingrix G722D did not exist, and was updated to G72ZD as per the sales database. There is a discrepancy in the reporting the outcome was reported in the structured field as not recovered/not resolved, but the outcome reported in the source document recovering/ resolving, however outcome is retain as per database fields.
Caller reports she received both doses in Mar2021 and was diagnosed with Covid-19 yesterday.; Caller reports she received both doses in Mar2021 and was diagnosed with Covid-19 yesterday.; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on Mar2021 as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received both doses in Mar2021 and was diagnosed with COVID-19 yesterday on 28Jul2021. The patient (45 years old, female) inquired about reporting testing positive for COVID-19 after receiving both doses of the Pfizer Covid-19 vaccine. She received both doses in Mar2021 and was diagnosed with COVID-19 yesterday. She received an email last night, she believed it was from something she sent in on the website, with a request to call us directly. She said "my cousin and his wife also got diagnosed a couple days earlier than I did. The patient just wanted to make sure this got reported because I know you are still trying to figure all this out. Especially when the patient found out her cousin and his wife had both doses and tested positive". On 01Apr2021, Pfizer and BioNTech announced an updated topline analysis up to 6 months following second dose of COVID-19 Vaccine. Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) is effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to 6 months after the second dose. Vaccine was 100% effective in preventing severe disease as defined by the Health Authority and 95.3% effective in preventing severe disease as defined by the Agency Vaccine was 100% effective in preventing COVID-19 cases, where the lineage is prevalento Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose Pfizer and BioNTech plan to share these results with worldwide regulatory agencies soon. The press release is available at: Withheld Please note that the Pfizer-BioNTech COVID-19 Vaccine-Antibody Persistence and Duration of Immunity. Data has been updated to include the Press Release information. Proposed response: Please confirm "Pfizer Covid 19 Vaccine" and speak from attached documents. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Within 24 hrs of the vaccine I experienced mild fever, chills, significant body aches, significant foggy head, headache, very rundown.  Lasted 24 hours. No treatment, went away on its own.
Pfizer-BioNTech COVID-19 Vaccine EUA  On 12/19/20 around 11:15 PM, patient experienced ?pinching? pain in armpit of left arm (arm of injection). Pain persisted throughout night with accompanying generalized underarm swelling (fluctuate). On 12/20, NSAIDs were taken to relieve pain. 1 dose of Advil were taken on 12/21 and 12/22 to manage pain. On 12/22, pain level on 1?10 scale was 8-9 in the morning with increased swelling, warmth, and discomfort. At night, swelling was less than that of morning. On 12/23 pain level was 3. No NSAIDs were taken and patient visited doctor at 10 AM. Upon examination, doctor made diagnosis of a localized lymph node/inflammatory response, possibly Cellulitis and prescribed Keflex to be taken 2 times daily for 10 days. Pain has mostly subsided (level 1 or 2 when it occurs), swelling has gone down but not completely resolved. Left underarm continues to feel fluctuate following day 2 of antibiotic regimen. Possible axillary lymph node reaction suspected.  Patient has also experienced persistent redness, swelling, mild pain and itchiness at injection site. Most of swelling and pain has subsided, itchiness remains.
Hepatitis A adult vaccine to a 16 year old patient; Hepatitis A adult vaccine to a 16 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old female patient who received HAV (Havrix 1440) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th April 2022, the patient received the 1st dose of Havrix 1440 (intramuscular) and Havrix Pre-Filled Syringe Device. On 25th April 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were 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: 26-APR-2022 Reporter's Comment: The patient received Havrix in right deltoid. She mentioned that, the patient received Menveo in left arm same day. The reporter stated that, she gave the patient a Hepatitis A adult vaccine instead of the Hepatitis A pediatric vaccine to a 16 year old patient. Additional Supportive Information:The reporter stated that, she gave the patient a Hepatitis A adult vaccine instead of the Hepatitis A pediatric vaccine to a 16 year old patient, which led to overdose and inappropriate age at vaccine administration.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070226:Same reporter - FU1 - Deleted
Headache (48-72 hours); Nausea; Fever; Chills; Fatigue; Joint pain; General soreness; This is a spontaneous report from a contactable consumer, the patient. A 24-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 20Apr2021 at 15:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol;norgestimate (TRI-SPRINTEC) for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. 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 30Mar2021 at 15:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 05:30, the patient experienced headache (48-72 hours), nausea, fever, chills, fatigue, joint pain and general soreness. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache (48-72 hours), nausea, fever, chills, fatigue, joint pain, general soreness was resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received varicella vaccine 12/6/07, seen 12/26/07 and diagnosed with varicella head to toe lesions. Seen again 12/28/07 and treated for Impetigo.
Pt experienced rash and swelling for approx 1 weeks post injection; rash from should to elbow. Stated had pain for about 1 1/2 months after injection.
Information has been received from a licensed practical nurse concerning a female who on 19-SEP-2006 was vaccinated intramuscularly (IM) with a first 0.5 ml dose of GARDASIL vaccine. Subsequently the patient experienced pain at the injection site. Unspecified medical attention was sought. It was reported that the patient did not return to complete the schedule.  Additional information has been requested.  This is in follow-up to report (s) previously received on 2/14/2007. On 14-DEC-2006, the patient was vaccinated with IM GARDASIL vaccine (lot # 654389/0961F) in the right deltoid. On 14-DEC-2006, the patient experienced pain in her arm, difficulty moving and lifting arm. The patient reported recovery from difficulty moving and lifting arm on 28-DEC-2006. The patient reported recovery from arm pain on 14-JAN-2007. Additional information is not expected.
dose of moderna vaccine for age 6 months - 5 years given in error instead of Moderna bivalent booster
I get a numb tingly feeling just like when your hand goes to sleep. It's under my left arm and reaches over to the side of my left breast and it doesn't last long but it comes and goes throughout the day.
Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 20-May-2022; Patient received vaccine after the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 20-May-2022) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 33K212A) for COVID-19 prophylaxis.     Patient was not ever diagnosed with/ tested positive for Covid-19.  There were no known drug allergies of the patient to medications, food and other products.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before. It was unknown if patient had any chronic or long-standing health conditions.    On 22-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-May-2022 at 4:00 PM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 20-May-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 20-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 20-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Total number of vials was 6 with Lot number 027L21A. The vial was initially stored in refrigerator on 08-Mar-2022. Total number of vials was 10 with Lot number 33K212A. The vial was initially stored in refrigerator on 28-Feb-2022. The vial did not undergo any temperature excursion. The patients had not reported symptoms. No treatment medications were reported.
1 hour after vaccine given patient started to have salty taste in her mouth and salty taste to food and drink 2 days after vaccine noted not able to hold water in her mouth and noted right facial weakness.  Progressed over the next 3 days to complete right facial paralysis ( OV 1/19/2021)  Follow up on 2/9/2021-  some improvement of facial paralysis -- approximately  50-75%