chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 10-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX QUADRIVALENT 2021-2022 SEASON). On 17th December 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 17th December 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device and an unknown time after receiving FLUARIX QUADRIVALENT 2021-2022 SEASON, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 age at vaccination was not reported. The patient received 1st dose of Fluarix Quadrivalent 2021-2022 on 16th October 2021 and 2nd dose on the day of reporting, which led to extra dose administered. The reporter consented to follow up.
Injection of 0.5ml Tdap given IM. Patient reported swelling at injection site over weekend. Swelling at injection site seen 10/26/2009 with reported itchiness at site of injections. Swelling at site as days progressed.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K000456 and expiry date: 15-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
First Vaccine Given on 3/15/2021. Pfizer. Lot EN6207. Intramuscular. Right Arm.
I have chronic, constant, and moderate (6 using a 0-10 scale with 10 most painful) osteoarthritis in both left and right knee joints, in part associated with prior knee reconstruction 20-years ago. I had the same unexpected event following dose-1 and dose-2 of the Pfizer SARS-C0V-2 vaccine. In both vaccination events the unexpected effect persisted for 72 hours post-vaccine delivery. Following each vaccine dose I had near complete relief from chronic pain in both knees. I had no detrimental adverse events associated with the vaccine (no injection site soreness, no fever, no fatigue, etc ...). However, the loss of pain and gain of range of movement in both knees despite the progressive osteoarthritis was marked. These seem like anti-inflammatory responses, which also seems counter to the immune systems response to the mRNA-derived antigen. After 72-hours the pain relief and range of motion returned to pre-vaccination levels without further incidence. I would be curious if any of the "inert" components (or the lipid NPs) of the vaccine have any prior indication of beneficial adjuvant use. The pain management gains were consistent and comparable between dose-1 and dose-2 of the Vx.
6-8 hours later: headache, fever, chills, right ear ache, felt like a sinus infection, diarrhea. Took tylenol
100% blocked LAD; initial symptom of slight burning/wheezing while swimming started the week after the vaccine. I continued to have this more often and what might be described as vague heartburn. No shortness of breath or pains to indicate a heart problem until Saturday evening 04/24. Very uncomfortable that evening and night but still did not think I was in serious trouble. Went to urgent care  Sunday morning where EKG and blood work were done. Transported immediately to the hospital for a stent
Alopecia areata, (hair loss in patches from the scalp, nape of the neck, behind ear); treated with two courses of intralesional corticosteroid injections, which resulted in some hair regrowth, but he continues to experience patchy hair loss on his head.
Pt informed me that after Rabies shot #1 at 11 AM on 7/14, she right away had muscle aches in back and shoulders. By 2 AM the aches had spread to her extremities and she felt like her throat was swollen, or closing. This feeling persisted for 2 days. Pt had the Rabies dose #2 at 11 AM on 7/21, she felt a swollen throat right away, and muscle aches in back and shoulders. She went home from work at 3 PM. She was having more muscle aches in her extremities as well, and worse than after dose #1, She felt she couldn't get up. She fell asleep, waking up with a fever at about 5 PM, and shakes. Symptoms persisted for 3 days. She took Benedryl and Advil.
mom states gave APAP q4hr about 6PM pt felt hot, not crying;t104 R;took to ER 28MAY97 dx bronchilitis & given ATB;MD told mom to call hlth dept to report since vax given 27MAy97;returned to ER 29MAY97 w/fever this AM 30MAy97 t102 R;
Teen reports today pain at injection site for 1 week, then pain resolved and noticed numbness at site, which then went down to fingers, and involving entire arm. Transient, sometimes causing weakness. Site today tender to touch but location varies during exam.  Full ROM
Guillain Barre Syndrome; This serious case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2023 The doctor said that her patient called to medical information and one of the representative agreed signs and symptoms could be related to Shingles vaccine the patient got in 2019 and agent wanted to speak with doctor and stated that the vaccine was Shingrix. The healthcare professional requested medical information for a patient who developed the Guillain barre syndrome after Zostavax vaccination on 2019. The reporter reported that this inquiry came in via voicemail, there was a possibility that the signs and symptoms was relating to Guillain barre syndrome after Shingrix as healthcare professional had spoken with an agent earlier to this case and said she would call back to confirm if it was Shingrix (although it was mentioned in voicemail it was Shingrix no other information was available). The reporter consented to follow up.
PATIENT RECEIVED FLUAD SHOT AT APPROX. 4PM ON 8/11/2017. PATIENT LEFT PHARMACY APPROX 10 MINUTES AFTER RECEIVING SHOT. I WAS CONTACTED BY FAMILY MEMBER ON 8/12/2017 THAT PATIENT HAD PASSED AWAY SOMETIME DURING THE NIGHT. IT IS UNCLEAR IF THE SHOT CAUSED THE DEATH NOR IS THE FAMILY STATING THAT THEY BELIEVE IT DID. I WAS ADVISED TO FILL OUT THIS FORM AS A PRECAUTION. AGAIN- IT IS UNCLEAR IF SHOT WAS THE CAUSE.
Started to experience unusual symptoms that I attributed to the flu vac--numbness, tingling, in addition to extreme soreness which began the day of the vaccine as expected; rash appeared Friday; sought treatment in ER Saturday & was diagnosed with shingles; still suffering & not able to work as of today, 11/16/2010; extremely severe case with intense pain; started on antivirals within 24 hours of rash appearance; on Vicodin and now am trying gabapentin.
Chills, fever and body ache for about 5 hours.  Mild headache for a few  days.  About 8 days out, red  splotches and super itchy arm.  This has lasted at least 7 days.  Really itchy arm!!!
85 year old female patient had high blood pressure and a headache after receiving the first dose; 85 year old female patient had high blood pressure and a headache after receiving the first dose; This is a spontaneous report from a contactable consumer (patient).  An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE ), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced high blood pressure and a headache after receiving the first dose. The headache would be off and on. The clinical outcome of the events high blood pressure and a headache were unknown.  Information on the lot/batch number has been requested.
Experienced chill, headache, abdominal pain, leg pain, fever for 3-4 days, in 5 th day headache reduces but abdominal pain persist. On day 7, abdominal pain was severe, feeling like fever, contacted PCP and as per PCP's recommendation went to ER.  ER report shows several liver Hemangioma, released from ER,  pain is is still there, taking pain medicine. Will check with PCP.  Had CAT scan before but never reported lever Hemangioma.
Tired after the first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired after the first dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired after the first dose). At the time of the report, FATIGUE (Tired after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported  Treatment details were not provided.   This case was linked to US-irms-MOD21-112442 (Patient Link).
RECEIVED INACTIVATED INFLUENZA VACCINE 10-24-05, GIVEN IM IN LT DELTOID. ON 10-25-05 AWOKE WITH A PRURITIC DRY RED PAPILLARY RASH INVOLVING NECK, TRUNK, BACK AND PROXIMAL LOWER EXTREMITIES.  SHE DID NOT FEEL NOR APPEAR ILL. HAD NO FEVER, RHINORRHEA, MALAISE. NO OTHER KNOWN EXPLANATION FOR THIS RASH. I TREATED HER TODAY WITH DIPHENHYDRAMINE BY MOUTH. No additional terms added from Discharge Summary rec'd 11/10/2005/sr
This case was reported by a consumer via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to the 1st dose received 2 and half months ago refer case US2018GSK111694). Concomitant products included gabapentin and trazodone. On 22nd May 2018 14:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th June 2018, 20 days after receiving SHINGRIX, the patient experienced rash, redness, itching, blisters, facial swelling and burning skin. The patient was treated with VALTREX. On an unknown date, the outcome of the rash, redness, itching, blisters, facial swelling and burning skin were not recovered/not resolved. It was unknown if the reporter considered the rash, redness, itching, blisters, facial swelling and burning skin to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced a rash and blisters accompanied with redness, burning, itching, and swelling on entire left side of her face going down to her chin. The patient stated that it was covering about 75 percent of the left side of her face. The patient called her doctor on 12th June 2018 and sent her pictures of the rash. The patient was currently taking VALTREX that her doctor called in to the pharmacy on 12th June 2018. The patient stated the rash was still getting worse. No further details were provided.
3 hours after the shot at 3PM. 30 minutes later I had a wrird taste in my mouth.  At 4PM I noticed my head was stuffy so I took an allergy pill.  But, at 6PM my body just shut down and the symptoms were aches from head to toe, fever, sore throat, coughing, stuffy head (completely), my lungs were hurting and I had cold shivers but was hot.  My feet felt like ice and I started coughing. This lasted until midnight when the Nyquil kicked in. I had to put a heating pad on my feet they were so cold.  I was sore all over and couldn't move much. I had some chicken soup to help.  Other than a stuffy head the next morning, some soreness in my body, I took a Dayquil to help with those symptoms.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: OOZING AT INJECTION SITE-Mild, Additional Details: PATIENT STATED THERE WAS REDNESS, SWELLING AND OOZING OF LIQUID AT INJECTION SITE.
Within 24 hours I had severe headache and arm soreness.  I started having localized tingling and numbness throughout body. It is felt like as if something is crawling under my skin. It itches slightly and then continuously moves to other localized spots all over the body. It has been persistent. I have continued to only feel this more after the 2nd dose through out hands, feet and face more.  After the 2nd dose I am experience some joint pain in feet/ face and increases tingling in extremities and face.
Now has a large scab; Biopsy showed it to be a herpetic infection /  Confirmed to be herpes zoster (shingles; Bump below her left eyebrow / which grew upto a the size of a nickel; She was in lot of pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2020, the patient received the 1st dose of Shingrix. On 19th October 2020, 3 days after receiving Shingrix, the patient experienced shingles, local swelling and pain. On an unknown date, the patient experienced scab. The patient was treated with valaciclovir hydrochloride (Valacyclovir), doxycycline and ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the shingles and pain were unknown and the outcome of the local swelling was recovered/resolved and the outcome of the scab was not recovered/not resolved.   It was unknown if the reporter considered the shingles, local swelling, pain and scab to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and by 19th October 2020 she noticed a bump below her left eyebrow, on the left side of the bridge of the nose, a bump which grew up to a the size of a nickel. The patient was in lot of pain. The patient saw at least 3 dermatologist and was at the HCP office at least 6 times. Initially she was treated with doxycycline and then was given a local cortisone cream. The third dermatology took a biopsy and suggested on 31st October 2020 that the biopsy showed it to be a herpetic infection, and on 6th November 2020 it was confirmed to be herpes zoster (shingles) and was given valcyclovir orally. The bump had healed and the patient now had a large scab.  The patient stated she had to get stitches after the biopsy was done. The patient stated prior to this incident she has never had shingles before. The reporter consented to follow up.
I noticed a very painful rash on upper left buttock approx. 30 hours after taking the Prevnar13 shot in my left arm. I went to the Dr. the next morning on 12/11/15 and it was verified that it was Shingles. Started on Valtrex & Neurontin immediately. I had my Shingles Vac. April 2013 Don't know if it's related to the Prevnar13? I'm retired and not under any stress. It has not spread anymore and starting to dry up as of 12/15/2015.
Has breathing problems; has COPD; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Has breathing problems) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (has COPD) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Breathing difficult (Breathing problems).   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Has breathing problems) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (has COPD). At the time of the report, DYSPNOEA (Has breathing problems) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (has COPD) outcome was unknown.            No concomitant medication information was provided. No treatment information was provided.  It was reported that the patient was not told or made aware about the patient's medical history before or after the primary series and booster shot vaccination.
PATIENT REPORTS BELL'S PALSY IN LEFT EYE AND HERPES IN RIGHT EYE ONE WEEK AFTER HAVING SHINGLES SHOT. SAYS HER RIGHT EYE IS EXPERIENCING DRYNESS AND SOME LOSS OF VISION.
Within 5 minutes burning at site of injection. Mild redness about 1" in diameter. Given 25mg diphenhydramine 25mg. Within 5 minutes burning subsided. Rash pink 1" in length 1/2" width.
No additional AE/PQC reported.; VARlVAX and MMRII that has been administered since the excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   Since 22-OCT-2020, the patient was vaccinated but it was unknow which of the following vaccines were administered: varicella virus vaccine live (Oka/Merck)(VARIVAX) 0.5 ml (route and site of administration were not provided) with lot numbers: T000698 was confirmed to be valid, expiration date 07-JAN-2022, T015999 was confirmed to be valid, expiration date 08-MAY-2022, T017688 was confirmed to be valid, expiration 21-MAY-2022; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (MMR II) 0.5 ml (route and site of administration were not provided) with lot number: T000890 was confirmed to be valid, expiration date 08-JAN-2022, S035354 was confirmed to be valid, expiration date 05-NOV-2021, S039312 was confirmed to be valid, expiration date reported as 24-DEC-2021 but upon internal validation was established as 04-DEC-2021.  The aforementioned doses of vaccines experienced the temperature excursion but exact temperature was unknown. The reporter stated that her "data logger" battery died and she had no temperature information for the freezer since 22-OCT-2020. No additional adverse event was reported.
Within 1 hr pain in right leg above knee; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Feb2021 07:45 at single dose for at left arm covid-19 immunisation. Medical history included type 2 diabetes, heart surgery in 2017, spinal stenosis, high blood pressure. Concomitant medications within 2 weeks of vaccination included metformin, metoprolol, gabapentin, glipizide, warfarin, acetylsalicylic acid (ASPIR). The patient experienced within 1 hr pain in right leg above knee on 12Feb2021 08:30 with outcome of not recovered. Patient didn't receive treatment for the event. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious.  Information on the lot/batch number has been requested.
About 2 weeks after her booster, patient lost her senses of taste and smell. They still have not returned. She said she tested negative for Covid-19
3 days after second vaccine began developing hives/rash on the arm where 2nd vaccine was administered. on 4th day after vaccine took Benadryl to help with hives. Saw some improvement during the day but that evening hives became more present. On morning of 5th day after vaccine went to clinic for examination of hives which were located on both arms, both legs and upper chest and upper back. There have been NO changes in my diet or soaps, lotions used on a regular basis. Doctor prescribed Prednisone 40mg for 5 days and continue taking Zyrtec 10mg in morning and Benadryl 25mg in the evening for 5 days. Started the treatment today 03/30/2021.
Red, itchy rash over entire body. Took Benadryl. It got better.
My adverse event started on the same day of receiving the 4th dose within 1- 2 hours. I started having flu like symptoms. I thought it was simple reactions of getting the vaccine so I just let it go and didn't think much. For 4 days the symptoms continued so I've decided to go to the Urgent care on 09/30/2022. They told me I had no infection I possibly had ear wax. They just cleaned my ears. On 11/09/2022 I went to the urgent care again and they advised me to get over the counter sinus medication. On 01/17/2023 I had a CLC done based on that the results were abnormal. They scheduled a Cardiologist visit for 03/02/2023. I had an abnormal EKG which showed I had heart attack in the past. he prescribed me with Crestor 5mg. He also ordered a TTE for 03/23/2023. I have a follow up with my doctor on 07/25/2023 and  follow up with Cardiologist on 09/07/2023. I am on strict low carb diet.
The next day felt very ill and Vomit (15 times), very weak, body aches, light fever (temp not taken). Lost weight 12 pounds in 2 days (gained back in 5 days). One pustule formed in addition to inoculation site.  Pt. popped pustule and 2 more formed (auto inoculation).
Case received covid vaccine and one booster as of November 2021, then was hospitalized for Covid in February of 2022. Hospitalized at: Hospital.  * COVID Assessment & Plan Presented with 1 day of dyspnea, found to be COVID+. CXR/CTA without pneumonia or PE. Suspect infection started 2-3 weeks prior given ageusia and congestion during that time. Is vaccinated against COVID with J&J and mRNA booster. Has multiple risk factors for severe disease but steroids/anti-viral therapy held given prolonged duration of time since symptom onset. Did intermittently require small amounts of supplemental O2 so discharged home with oxygen. Counseled to isolate as able until symptoms resolve, including being fever-free for over 24 hours.   Severe sepsis  Assessment & Plan Met criteria for severe sepsis on presentation with fever, tachycardia, elevated lactate. Was treated appropriately with 30 ml/kg fluid bolus. This was attributed to COVID-19 and there was no evidence of separate bacterial infection.  12:38 PM 2/18/2022    Source of Infection: Viral Sepsis (including COVID-19) SIRS Criteria: Temp >38 C or < 36 C, HR > 90 Acute Organ Dysfunction: Lactic Acidosis (Lactate > 2.0) Shock: Not Present Based on the above findings, the patient has evidence of: Severe sepsis (Sepsis + Acute organ dysfunction) 30ml/kg bolus was ordered.
After receiving flu vaccine, patient had a scattered, generalized rash and received an injection of dexamethasone 10mg while in the ED.