chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office manager concerning a 64 year old female patient with allergic reaction to erythromycin and no pertinent medical history who on 12-SEP-2011 was vaccinated IM with a dose of PNEUMOVAX 23 (lot number: 668009/1174Z, expiration date: 10-MAR-2012) into the right deltoid region, 0.5 ml. Secondary suspect vaccine included a dose of ADACEL into the right deltoid region. Concomitant therapy included CLIMARA and probiotics formula (unspecified). On 13-SEP-2011, the patient was seen by the physician. At that time, the patient presented with redness and swelling from her right shoulder to her elbow. On unspecified date, unspecified lab work was performed on the patient and it was determined that the patient's white blood cell count was elevated and that the patient had a fever of 101F. The physician recommended that the patient go to emergency room. Patient drove herself to the emergency room and was admitted to the hospital until 15-SEP-2011. The patient was diagnosed with cellulitis and sepsis. At this time on 20-SEP-2011, the patient was still recovering. Additional information has been requested.
p/vax pt devel an inj site rxn characterized by pain & redness extending4 inches down to axilla;
After injection the recipient felt dizzy, nauseated, and had a burning sensation at site of injection. Patient was transported to the emergency department for evaluation.
Globus sensation, throat swelling but able to breath, talk and keep water down. 20-30 mins after injection
Tinnitus in both ears, frequency somewhere around 6,700 to 7,400 hz
Syncopal episode post approx 10 min post injections (H1N1 and Gardasil)
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 2:32 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 2:32 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.  No treatment medications were provided.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
No adverse events occurred; however, the first dose of Moderna was an incorrect administration based on the patient's age; Provider noted incorrect administration of 1st dose realizing that Moderna's EUA had only approved administration of this vaccine for those 18 years old. The series was completed per CDC guidance for incorrect doses given to patients 16yo-17yo. The patient and guardian were informed and reported no side effects.
Extreme pain-unable to move arm, mother up all night long in severe pain. No pain meds were affective in relief of pain.
nerve vibration on both legs, both feet, both hands, both knees, and back.; nerve tingling both legs, both feet, both hands, both knees, and back.; numbness on both legs, both feet, both hands, both knees, and back.; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (nerve vibration on both legs, both feet, both hands, both knees, and back.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced NEUROPATHY PERIPHERAL (nerve vibration on both legs, both feet, both hands, both knees, and back.) (seriousness criterion medically significant), PARAESTHESIA (nerve tingling both legs, both feet, both hands, both knees, and back.) and HYPOAESTHESIA (numbness on both legs, both feet, both hands, both knees, and back.). At the time of the report, NEUROPATHY PERIPHERAL (nerve vibration on both legs, both feet, both hands, both knees, and back.), PARAESTHESIA (nerve tingling both legs, both feet, both hands, both knees, and back.) and HYPOAESTHESIA (numbness on both legs, both feet, both hands, both knees, and back.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was no provided.  Patient had reached out to HCP who has done blood test and MRI  Patient did not have her vaccination card present and unable to provide lot #sor expiration dates of the products. Patient stated that the adverse events started few days before (11Jun2021) her 2nd dose of the vaccine. The adverse events were still ongoing Patient has reached out to HCP who has done blood test and MRI. Physicians were still not able to figure out the cause. Patient has not been prescribed any medications to alleviate the symptoms by HCP. Patient gave safety consent to follow up via email. Patient gave consent to follow up with vaccination site.; Sender's Comments: This case concerns a 56-year-old, female subject with no significant medical history reported, who experienced the unexpected events of neuropathy peripheral, paresthesia, and hypoaesthesia. The events occurred 5-days prior to study drug administration. The rechallenge is not applicable in this case. The reporter's assessment is not provided in this case.The benefit-risk relationship of the vaccine is not affected by this report.
12/16 weakness in legs/feet. Hypersensitivity over all body. Progressive ascending paralysis including hands. Hospitalized 12/25-26, ICU, currently decreased sensation/weak upper extremities. Paralysis from untulitus-feet. The medical record received on 1/16/04 states parathesis, chest congestion, URI, body aches, fever/ chills, urinary retention, prostitis, gait unstable, subacute necrotizing myelitis/ transverse myelitis, constipation and stiff neck. The discharge summary received on 3/23/04 states mild bsilar atelectasis, liver function abnormalities and ascities. The medical record received on 3/23/04 states auto-immune process and viral syndrome. 60-day follow up on 04/21/04: "Pt has not recovered from adverse events.  In wheel chair, nerve pain, decreased pain sensation in legs.  Continues to receive physical therapy for condition.  Pt continues under a physician's care for the GBS." Per annual follow up currently is able to walk, has no numbness from about the umbilicus down.
SLEEP DISTURBANCE; BODY SORENESS; MILD NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On MAR-2021, the subject experienced sleep disturbance. On MAR-2021, the subject experienced body soreness. On MAR-2021, the subject experienced mild nausea. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleep disturbance, body soreness, mild nausea and headache was not reported. This report was non-serious.
3-17-21 1:10PM  PT STATES HE 'DOESN'T FEEL WELL'.  SYNCOPE APROX 1 MIN - WIFE HELD PT IN CHAIR.  RN X3 AND MEDIC ASSISTED PT TO FLOOR AND ELEVATED LEGS. PT BECAME RESPONSIVE. PT PALE AND DIAPHORETIC. 1:16PM ASSISTED PT TO CHAIR 'FEELS BETTER NOW'. A/O, PINK, W/D, RESP REG WITH EASE. WIFE HERE TO DRIVE PT HOME. 3-19-21 3:30PM TC: PT STATES 'FULL RECOVERY'.
Expired dose / (expiration date: 3/2021) was administered to a / patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA354A, expiry date 31st March 2021) for prophylaxis.   On 24th June 2021, the patient received Menveo. On 24th June 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: Office Manager reported that an expired dose of Menveo was administered to a patient which led to expired vaccine used.  At the time of the report the patient has not reported any issues.  The lot was expiry only for the powder component.  The liquid component of the vaccine was still in date. The reporter consented to follow up.
Diarrhea Bilat eye puffiness, right sided head congestion, nasal drip and diarrhea; lethargy last night; resolved.
I received the vaccine at approximately 1 p.m.  in my left arm.  I informed the technician that I had allergies and had previously had anaphylaxtic reactions to foods and some medications.  I had noticed that the Pharmacy was not requiring people to stay after receiving the vaccine, so I told the technician that I would stay until I was sure I did not have a reaction.  No one came to check on me, and in about 15 minutes, I noticed that my scalp was starting to itch and my face felt hot.  I decided to go home, which was only a 5 minute drive from the store.  I took off my mask in the car and discovered that my face was very red and starting to feel tight.  I got home and took 1 Benadryl pill. By the time I got home, around 1:25 my ears were itchy and my lips were starting to swell.  I waited an hour and started to feel better, the color in my face was returning to normal, and I had no swelling of my throat, which I have experienced with food allergies.  At hour 2 I took a second Benadryl and went to sleep for 2-3 hours.  When I woke up, I felt better, my lips were still slightly swollen, but my face, scalp and ears were back to normal.
Fever 102F in armpit controlled with Tylenol for 3 days. Visited urgent care clinic 5/21, diagnosed with infection and given amoxicillin. On 5/23, a mild rash has developed all over his body.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 at 12:00 as dose 1, single (Lot number: EL3246), on 16Feb2021 at 13:00 as dose 2, single (Lot number: EL3246), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took a Covid  test that was again positive; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient treatment of Paxlovid started on 25Jan2023 and stopped on 30Jan2023, lot number: GF3965. No known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
pt woke up the next day after receiving the vax hurting in both shoulders.  The pain spread to entire body.  Pt had an appt already scheduled w/ Dr. to have blood work on 2/2/2021.  Reactive Protein went from 128 to 246 and is now 259.  He was given a shot, possibly steroid, for the pain.  After getting home the pain got worse and moved down his back and his belly.  Pt has had this pain since 2/2/2021.  Pt now has muscle pain in both legs for last 3 days.  He is using  cannabis care cream for his body aches and pains.   Pt is sick to his stomach all of the time and sugar is high now around 306.  On 2/24/2021 pt went to the hospital for xray and pet scan w/ no new results found.  Pt is to FU w/ Dr.
Pt recv vax on 10/6/98; post vax pt exp rash on left thigh vax site. Follow up received on 7/5/2001: From correspondence received at Aventis Pastuer Inc. on May 2, 2000, it was reported that the patient's parent called stating the child had a red rash on thigh at IPV IPOL vaccination site of Oct 6, 1998. Noticed approximately 24 hours after injection the patient scratching area, whole upper thigh covered with rash. Parent was advised to apply Benadryl cream to area per after hours nurse. The rash improved the next day. The patient reportedly recovered from this experience. This case is closed.
HYPOXIA 5/12/2022 COLITIS  HYPOXIA 5/12/2022 DIARRHEA  HYPOXIA 5/12/2022 DYSPHAGIA  HYPOXIA 5/12/2022 SEPTIC SHOCK
Fever; sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and INJECTION SITE PAIN (sore injection site arm) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and INJECTION SITE PAIN (sore injection site arm). At the time of the report, PYREXIA (Fever) and INJECTION SITE PAIN (sore injection site arm) outcome was unknown.            The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-169099 (Patient Link).
On December 30 I woke up itchy all over body. Itching persisted through the day. Night of December 30, I noticed red marks and small bumps on groin, arms, and armpits (hives). Hives continued for several days. I also had difficulty swallowing at night; it felt like there was something stuck in my throat. On January 1, I went to immediate care and was diagnosed with hives. Doctor noted it may be because of booster shot received two weeks prior. Doctor prescribed fexofenadine 180 mg and famotidine 20mg for symptom relief. On January 2, I woke up with swelling in feet and wrists. It was painful to walk on foot because of swelling. I returned to immediate care. Doctor prescribed six day course of methylprednisolone and to continue with fexofenadine and famotidine. Hives, itchiness, and redness significantly reduced but still persisted; I have had no foot or wrist swelling after first day of methylprednisolone. As of today (1/12/2022) after stopping methylprednisolone, I typically wake up in morning with red face and itchiness in my body. After taking fexofenadine 180 mg, hives are reduced but re-appear sporadically throughout the day. Hives also typically flair up at night. Trouble swallowing has mostly stopped.
Pt started w/pain lt deltoid 11JUN91; Started w/pain & redness 12JUN91; vax given 10JUN91 evolved into cellulitis which responded to Cloxacillin, warm packs;
Approximately 7-10 minutes after administration, MA notified this RN that pt was pale, diaphoretic, and felt faint. Upon entering exam room, pt was sitting in the procedure chair at a 45 degree angle. Her lips were pale, she was slightly diaphoretic, alert and oriented x 3. This RN placed pt in Trendelenburg position. After 2-3 minutes pt's lips gained faint pinkness, she stated she was starting to feel a little bit better. MA obtained pt vital signs and remained in room with patient. Blood pressure 98/82 with 98F tympanic. This RN re-checked pt after 5 minutes in Trendelenburg position. Pt has regained full color in her face and lips. She is no longer diaphoretic. She states she feels 90% improved and feels she can leave comfortably. MA rechecked blood pressure, now up to 118/60. Pt slowly stood up from the procedure chair with this RN and MA by her side. MA walked with patient to the parking lot. Pt left clinic in stable condition with no concerns.
body pain/ feeling like he was hit by a truck; This case was reported by a nurse via sales rep and described the occurrence of general body pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by nurse for himself. The age at vaccination was not reported. The patient felt like he got hit by a truck for a few days after getting the first dose of Shingrix. The symptoms he experienced were not enough to prevent him from getting the second dose of the Shingrix.  No additional details were reported. The reporter consented to follow up.
Within a few minutes after administration of patient's first dose of the Pfizer COVID19 vaccine, patient started feeling lightheaded and sweating. We instructed the patient to lie down in the pharmacy area and put a cold water bottle on top of patient's forehead and turned a fan on near the patient. Patient never lost consciousness and was responsive the entire time. Patient felt better after staying in the pharmacy area for about 30 minutes and left on his own afterwards.
patient passed out 8-10min after the shot  appear to have a seizure ... ems did not arrive  for 30 min but pt came back to and able to talk 2 nurses were also on site
Patient complaints of dizziness and anxiety which resolved over time. Patient was given water to hydrate.  EMS evaluated patient. Patient felt better after hydration.
Left upper arm red, swollen and hot to touch. Painful to child. To ER Tx with Prednisone, Ampicillin. Improved by 7/17/06.
After the 1st dose she had a low grade fever for 9-10 days; felt washed out, & felt tired all the time; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After the 1st dose she had a low grade fever for 9-10 days) and FATIGUE (felt washed out, & felt tired all the time) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Trigeminal neuralgia (History of Trigeminal neuralgia for 7 years.), Fibromyalgia (History of Fibromyalgia for years.) and Chronic migraine (History of Chronic migraine for 20 years.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (After the 1st dose she had a low grade fever for 9-10 days) and FATIGUE (felt washed out, & felt tired all the time). At the time of the report, PYREXIA (After the 1st dose she had a low grade fever for 9-10 days) had resolved and FATIGUE (felt washed out, & felt tired all the time) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-367530 (Patient Link).
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 24, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced  dizziness, vomiting and nausea, onset Mar 2021, with outcome of recovered (Mar 2021). Patient stated 6 hours later, she experienced dizziness and vomiting for one day. She experienced nausea for two days but felt better today. No follow-up attempts possible. No further information expected.
Stomach pain; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received Shingrix. On 3rd June 2022, 8 days after receiving Shingrix, the patient experienced stomach pain and vomiting. On an unknown date, the outcome of the stomach pain and vomiting were unknown.   It was unknown if the reporter considered the stomach pain and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: This case was self reported by patient. The patient received the dose of Shingrix vaccine last week before the day of reporting into right arm. The reporter reported that today (on the day of reporting), starting at six am, patient began to experiencing stomach pain and vomiting.  AE (adverse event) filed. The reporter consented to follow up. The reporter provided limited information. It was not disclosed if this was the first or second dose of Shingrix.  The reporter provided consent to follow up with HCP (Health care professional) (pharmacy).
Area below were  vaccine was administered started showing redness patch that appeared.  There is no external itching but  I feel a different sensation underneath the skin. The patch goes away after taking Allegra.
pain, tenderness & swelling @ the site of inject; pt returned to clinic 27JUN lt arm sore & swollen; pt returned to clinic 29JUN92; pain & tenderness much better; MD states it is not allergic rxn;
Patient came to pharmacy the following day concerned that she got a different vaccine than intended. Stated she had significant itching & pain, without rash.
pt recvd vax; fever 103.5 lasting for 3 days p/ vax; lethargy, crankiness; T dropped to 96.5 p/ 3rd day; cold to the touch;