chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is the second of 3 reports. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced passing out. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018353910 similar report from same reporter; US-PFIZER INC-2018357773 similar report from same reporter.
Expired vaccine used; no adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not provided. Patient was given expired dose, contacted Moderna lot analysis and determined  that vaccine maintained the activity necessary to protect. For bivalent, the date moved to refrigeration was on June 7, 2023 and published expiration date was May 23, 2023, the date of administration was June 8, 2023 for Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Lot: 010H22A The date moved to refrigeration was June 7, 2023, published expiration date was May 30, 2023 and date of administration: June 8, 2023 for Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Lot: 019H22A The below are Lot that were put in fridge to thaw and Administered 010H22Awas thaw on 07 Jun 2023 and administered on 08 Jun 2023  For 015B22A thaw on 08 Mar 2023 and administer on 09 Mar 2023 For 015B22A thaw and administer on 22 Mar 2023 For 015B22A thaw on 10 Apr 2023 For 015B22A thaw on 10 Apr 2023 and administer on 13 Apr 2023. For 015B22A thaw on 12 Apr 2023 and administer on 13 Apr 2023. For 019H22A thaw on 07 Jun 2023 and administer on 08 Jun 2023 Later mail was received, for lot 015B22A was put in fridge on 22 Mar 2023 and administered on 23 Mar 2023. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732753, US-MODERNATX, INC.-MOD-2023-732768 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2023: Live follow-up received iNarrative updated On 11-Jul-2023: Live follow-up received iNarrative updated On 21-Jul-2023: Follow up received and added patient details, added suspect dosage information, updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732753:Bivalent (MOD-2023-732749 - Monovalent) US-MODERNATX, INC.-MOD-2023-732768:Bivalent case ( (MOD-2023-732749 - Monovalent))
shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a non-contactable consumer. A 65-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not available/provided to reporter at the time of report completion), via an unknown route of administration on 25Jan2021 at 10:00 AM at a single dose at the age of 65 years old for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included at the age of 64 years, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 25Jan2021 at 22:00, after receiving 2nd dose of COVID-19 vaccine in morning, patient experienced chills, shaking, fever, joint pain, loss of appetite, and headache later that evening. She stayed home from work for 2 days and felt better 48 hours later. The reporter assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, if patient was tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling/heat/redness at injection site starting the night of the injection, progressively increasing in size over the course of 2 days until it reached the size of a golf ball. Noted that size remained the same after day 2 going into day 3. Severe body aches and chills noted for the following 2 days after the injection that subsided with staggered doses of Tylenol and naproxen, as well as ibuprofen taken approximately every 24 hours.
Onset of headache 7-8 hours after injection  Restless light sleep the night following injection (potentially caused by fever) Fever of 100.3 noted upon waking the following morning Inability to sleep and generalized muscle aches over the course day following injection  Fever of 100.7 noted 24 hours after injection 650mg Tylenol taken 26 hours after injection--All symptoms (headache, fever, muscle aches, inability to sleep) cleared within one hour of taking Tylenol Intercostal muscle soreness with no apparent cause localized to upper left side 48 hours following injection-- cleared within 24 hours
First vaccination took place on 1/26/21. Second on 2/23/21. Provider reports that the patient has been hyperglycemic without explanation since the first injection. Has increased units of Lantus.
About 12 hours after the shot I had rolling chills, chattering teeth, bone pain, muscle aches, and felt poorly. At around the 14 hour mark, I got debilitating nausea and a fever that reached 102.1. I vomited from about 12am-3:30am solid. I was able to go to sleep around 5, awoke at 7 with pain and nausea again, took a Tylenol, and was able to go back to sleep. I slept until 2:30pm. I still had joint and bone aches and a bad headache and a lower fever of about 101. That dissipated throughout the evening (Tuesday evening). Wednesday I felt a bit better aside from a very sore neck and headache. I took another 1000 mg of Tylenol on Wednesday. Today (Thursday), I woke up with pretty significant vertigo. I have placed a call to my primary care provider. I still have some lingering neck pain as well.
Fever, chills, headache, pain in injection site, chest pain, body aches.
PATIENT WAS WAITING IN POST-IMMUNIZATION CHAIR AFTER RECEIVING VACCINATION.  HAD A SEIZURE AND FELL OUT OF CHAIR AND HIT THE BACK OF HIS HEAD ON THE FLOOR.  HE WAS LYING ON HIS SIDE AND I RAISED HIS ARMS TO ENSURE PROPER AIRWAY.  HE RECOVED COHERENCE AND HAD NO BREATHING DISORDER AND BECAME AWARE OF INFORMATION.  HIS HEAD HAS A "BUMP" ON IT (~ QUARTER SIZE).  TRANSFERED BY EMS AND RETURNED WITH HIS FRIEND  IN ~ 45 MINUTES TO GET IMZ CARD AND WAS COHERENT.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 14:00 as dose 10 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 6 (booster), single (Batch/Lot number: unknown), as dose 7 (booster), single (Batch/Lot number: unknown), as dose 8 (booster), single (Batch/Lot number: unknown) and as dose 9 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX via plaque forming unit (lot # L024997, expiration date 06-OCT-2016; dose not reported) intramuscularly in the upper, posterior aspect of left arm. On an unknown date the patient developed redness at the injection site an unspecified period of time after receiving the ZOSTAVAX. The reporter stated that the patient was not exhibiting a rash. The outcome of the event redness at the injection site was unknown. Causality assessment was not reported. Additional information has been requested.
(1st shot) next morning dizzinext , blurred vision gone next day occasional dizziness troughout the month, covid arm (2nd shot) next day fever chills migraine , (02/27/2021 - present) woke up dizzy vertigo ear pain inflammation neck pain vision problems
Member complains of "severe itching" from head-to-toe.  Member given BENADRYL & CLARITIN by doctor.
About 5 hr after IZ started with tenderness, sl swelling to injection site. Today approximately 10 cm raised, pink, tender injection site reaction. No s/s secondary infection.
VACCINE WAS NOT HANDLED RIGHT BEFORE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine was not handled right before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was not handled right before administration was not reported. This report was non-serious.
patient forgot to come back in for Gardasil 9 #2 injection, so patient was given dose #2 today; This spontaneous report was received from a healthcare worker and refers to an adult male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was provided. On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was reported that the patient forgot to come back for the second dose of vaccine and it was administered to him on 10-JUL-2019 (reported as today).
I have a fever and cough really bad body aches and pains. My arm is dead and I can?t move it
A week after I had my first dose of Pfizer I got a cold sore. This is not uncommon for me as I?ve had them pretty much my entire life. Before the one I got on Monday 9/13 even healed  I got  a second cold sore. Now like I said I?ve had these my entire life and I have never once had two cold sores at the same time or even within weeks of eachother.
Rash; Had a reaction; This is a spontaneous report received from Pfizer sponsored program. A contactable female consumer reported for her daughter. A female patient with unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot number and expiry was 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. On an unspecified date, the patient experienced rash, a week afternoon her arm and had a reaction. The patient didn't know what it was until her husband looked it up. It said that 7-10 days after the shot a rash can occur. No investigations were reported. Outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number are requested.
Pt. with several food allergies. Has had anaphylaxis to nuts. Hx. of asthma. About  10 min. after injection she started itching and face got warm and red. No SOB, neck swelling or tongue swelling. She states she recognized symptoms being similar to taking oregano. When this happens she takes Benadryl and Prednisone 20mg QD x 3 days.  On exam: In no acute distress. Sat 98%. resps 14 and HR 76. Lungs CTA, heart regular. Face is red. No neck, pharyngeal or tongue swelling. Pt. given 25mg Benadryl and 20 mg PO prednisone. Watched an additional 40 mins.  At d/c, face  much less red. Stopped itching , lungs CTA and throat normal.  Pt. to continue benadryl Q 4hs PRN at home. Take prednisone 20mg QD x 3 days. She has an epi pen if needed. She is to go to ED or UC for further problems with breathing or swelling. She is to take 25mg PO 25 min. prior to her second injection in 3 weeks.  Information provided by Dr.
Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; sore arm; This is a spontaneous report from a contactable consumer (the patient).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0151), dose 1, single dose via an unspecified route of administration, administered in arm  left on 14Apr2021 for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. Past drug event included allergy to ampicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced minor allergic reaction, swollen, tingling, and numb tougue and lips and sore arm on 14Apr2021. Therapeutic measures taken as a result of minor allergic reaction, swollen, tingling, and numb tougue and lips. and sore arm included diphenhydramine (BENADRYL). The outcome of minor allergic reaction, swollen, tingling, and numb tongue and lips, sore arm  was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of minor allergic reaction cannot be excluded.
Patient received MMR vaccine 0.5ml in Right tricep. Seen by provider following vaccine.
8 hours after vaccination I had a fever, vomiting, body aches, chills, I fainted, and had extreme leg pains. The symptoms went away after 24 hours. I took acetaminophen when the symptoms started and for the next 48 hours after.
Recieved vaccine dose 1 on 1/5/21, recieved dose 2 on 1/25/21. Was exposed to COVID19 on 3/10/21, developed symptoms (chills, body aches, sore throat, runny nose, weakness)  on 3/12/21 and tested positive for COVID on 3/13/21 via rapid and PCR.  Still recovering from symptoms on 3/15/21 (still body aches, weakness, runny nose, congested feeling). Health Department and lab facility unable to hold specimen for variant testing.  Per CDC guidelines, reporting this since I am a healthcare provider and was fully vaccinated since 1/25/21.
Pt's right thigh was red and hot to touch - over entire thigh.  Apply warm compress to area per MD. Pt temp 98.6 degrees.
first shot was pretty painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (first shot was pretty painful) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (first shot was pretty painful). At the time of the report, VACCINATION SITE PAIN (first shot was pretty painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2022-472572 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and 10PN-PD-Dit (Pneumococcal vaccine). On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness, feeling hot and cold, nausea, shivers, pain and feeling cold. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the tiredness, feeling hot and cold, shivers, pain and feeling cold were unknown and the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the muscle pain, tiredness, feeling hot and cold, nausea, shivers, pain and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX 2.5 months before the date of reporting and she did not feel sick after the 1st dose. The patient received her 2nd dose of SHINGRIX and a pneumococcal vaccine on 15th August 2018, but on 16th August 2018 she felt achy, nauseated, shivery and tired, every muscle in her body ached. The patient felt like she could not stay awake she was so tired, She would feel hot for a few seconds, and then feel very cold, she had not taken her temperature.
2 days after the shot I have had waves of mild nausea and very mild dizziness that comes and goes. Tomorrow will be 1 week and Im continuing to experience these symptoms. I have not experienced any other symptoms besides these.
I don't know, she tested negative for COVID with almost like she had symptoms of one whole COVID, and its lasted for about three days; Headache; tired/fatigue; she couldn''t get out of bed; she is like completely bed within.; She was dizzy.; She have a cold; brain Fogg; she was completely disoriented, she couldn't function; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Lot number: TJ1620) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic cough" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: she had breast cancer like several years ago like probably 15-20 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "extreme fatigue", "brain Fogg"; Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "extreme fatigue", "brain Fogg". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 01Jan2022, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 01Jan2022, outcome "unknown", described as "tired/fatigue"; MOVEMENT DISORDER (non-serious) with onset 01Jan2022, outcome "unknown", described as "she couldn''t get out of bed; she is like completely bed within."; DIZZINESS (non-serious) with onset 01Jan2022, outcome "unknown", described as "She was dizzy."; NASOPHARYNGITIS (non-serious) with onset 01Jan2022, outcome "unknown", described as "She have a cold"; FEELING ABNORMAL (non-serious) with onset 01Jan2022, outcome "unknown", described as "brain Fogg"; DISORIENTATION (non-serious) with onset 01Jan2022, outcome "unknown", described as "she was completely disoriented, she couldn't function"; SUSPECTED COVID-19 (non-serious), outcome "recovered", described as "I don't know, she tested negative for COVID with almost like she had symptoms of one whole COVID, and its lasted for about three days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, headache, fatigue, movement disorder, dizziness, nasopharyngitis, feeling abnormal, disorientation, suspected covid-19.
swelling at injection site; redness at injection site; hot to touch at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number G72ZD, expiry date 30th November 2020) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st July 2019, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and skin warm. On 4th July 2019, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingix in left arm. The pharmacist reported that the injection site reactions the patient experienced spread throughout her left arm.
I received the Pfizer Bivalent COVID-19 booster and a flu shot on 9/24/2022. On 12/23/2022, while I was on vacation abroad, I started having body aches. They started in my legs, but since I have fibromyalgia, I thought I was just having a flare-up. My voice also went hoarse. I also took Tylenol and Motrin and stayed in my room. I also tried to stay hydrated. The body aches then got worse, and I felt feverish. On 12/25/2022, a doctor paid me a house call. He took my temperature, which was 100.5. He then performed a rapid antigen test for COVID-19, and the result was positive. He then gave me Co-Codamol and Children's DPH Cough and Cold. Since it was a children's cold medicine, he recommended that since I am an adult, I should take double the dose recommended in the instructions. He recommended that I isolate the remaining 5 days of my trip. He also left me another antigen test to take before I left to go home, and he also said that he would notify the front desk of the hotel of my status. The medicines worked immediately on the fever and pain. I flew home on 12/30/2022. I continued to test positive until 1/5/2023, so I have been isolating in my room at home since returning from the trip. The only symptom that remains is the cough, but otherwise, I'm fine.