chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my body hurts all over; flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (my body hurts all over) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). On 23-Jan-2021, the patient experienced MYALGIA (my body hurts all over). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and MYALGIA (my body hurts all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: (High) 98.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Beginning on the third day I experienced slightly blurred vision and chest tightness as well as rapid heart rate while lying down. By the 5th day I had more rapid heart rate episodes (very short; about 30-40 seconds) but this time it was followed by intense dizziness and darkened vision and almost passing out. I almost wen to urgent care, but decided to take it easy and see a doctor on Monday. Unfortunately, the same thing happened the next day but even longer (on and off for 15 minutes) and it was a Sunday so I had to go to the Emergency room.
I caught COVID. Its basically been congestion, fatigue, some coughing and that's about it. I've also had a slight loss in appetite.
ANXIOUS, FEEL FAINT, CODE GREEN CALLED BP 110/72 , HR 60, SX IMPROVED, REFUSED TRANSPORT.
Got tested for COVID-19 about 10 days after the first dose and the result was positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (husband) reported that a female patient (wife) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 17Mar2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The reported stated that he and his wife received their first dose of the vaccine on 17Mar2021. He and his wife got tested for COVID-19 about 10 days after the first dose and the result was positive on 27Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 30th April 2019). Previously administered products included ZOSTAVAX (received in 2017). On 23rd April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 24th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. The reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the day after she was vaccinated with SHINGRIX on left arm, she experienced injection site soreness. The patient took BENADRYL and it helped but she called the pharmacy today and stated that the redness comes and goes and the area was itching. The patient was concerned that ZOSTAVAX vaccine could be related to her symptoms.
Brain fog, Full body aches, Pain still on right side of body, reduced hearing in right ear
Patient called covid hotline. Reports she got the vaccine 10 days ago. Since then she has had symptoms on and off. 2 days after the vaccine she had joint pains that resolved the next day. Now she is having fatigue on and off, but she is still able to do her usual activities including walking 1-1.5 miles/day. She also reports right sided breast tenderness and lymph node swelling. It occurred several days after the vaccine and has since resolved. She got the vaccine on the left deltoid. She denies any covid symptoms including headache, sore throat, cough, congestion, or fever. No known exposure.
Injection site pain, painful/swollen lymph nodes under left arm, mild fever, chills, headache, body aches. No symptoms until 24 hours after vaccine administration. Symptoms dissipated completely after another 24 to 48 hours
10 days after the second shot I was in excruciating pain for 36 hours.; It was like I had shingles all over again without the rash.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old patient of an unspecified gender received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: ER8737) via an unspecified route of administration in arm left on 01Apr2021 as dose 2, single (age at vaccination: 70 years) for COVID-19 immunisation. Medical history included shingles, post hermetic neuralgia, both from an unknown date and unknown if ongoing I have suffered from post hermetic neuralgia since having shingles in 2013. Concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EN6206) via an unspecified route of administration in arm left on 11Mar2021 12:00 AM as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks, no known allergies. No COVID prior vaccination and did not tested COVID post vaccination. The episodes post hermetic neuralgia can be painful and erratic. I had gotten used to the pain. On 18Mar2021 12:15AM, after my first shot I noticed I was having more occurrences of problems with the PHN. On an unspecified date Apr2021, 10 days after the second shot I was in excruciating pain for 36 hours. It was like I had shingles all over again without the rash. The severe pain subsided within three days So I am just back to my normal PHN issues. The clinical outcome of the event 10 days after the second shot I was in excruciating pain for 36 hours was resolving and the event it was like I had shingles all over again without the rash was unknown.  No follow-up attempts are possible. No further information is expected.
Localized erythema, warmth, edema at vaccination site (left deltoid), 4 cm by 4 cm
Erythema and mild edema in the (R) thigh, no induration or fluctuance.
the day after my second dose, I had one of the worst migraines of my life.; This is spontaneous report from contactable consumer or other non-HCP (patient). A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration in Arm Left on 23Apr2021 15:45 (age at the time of vaccination 19-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK8737), via an unspecified route in Arm Left on 01Apr2021 15:45 (age at the time of vaccination 19-years-old), as a single dose for COVID-19 immunization. The patient's medical history included chronic migraines. The patient's concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced the day after my second dose, I had one of the worst migraines of my life. No treatment was received. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included post herpetic neuralgia and shingles (3 months ago before the date of reporting). On 7th January 2019, the patient received SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), post herpetic neuralgia, shingles and condition aggravated. On an unknown date, the outcome of the vaccination failure, post herpetic neuralgia, shingles and condition aggravated were unknown. It was unknown if the reporter considered the vaccination failure, post herpetic neuralgia, shingles and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient age could be around 70 to 72 years. The patient received SHINGRIX vaccine and felt that his post herpetic neuralgia was worse now following receipt of the vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown.
This spontaneous report was received from a physician referring to an unspecified patient of "less than 2 years of age" and unknown gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was inadvertently vaccinated by mistake with RECOMBIVAX HB, (dose, route of administration and lot # were not reported) for prophylaxis instead of a dose of VAQTA. It was unknown if the patient had received any previous doses of RECOMBIVAX HB or what caused the medication error. No further information was provided. Additional information has been requested.
She had some joint pain within a few days of the vaccine. Then on Oct.  4, she began having significant hand weakness. She was unable to write well. She could not cut her food.  She saw her primary care provider on Oct. 5 who ordered a neurological consult. The neurologist ordered a nerve conduction study.  The study ruled out GBS. The neurologist conducting the study suspected transverse myelitis but did not order further testing b/c treatment options would be limited. Patient also began struggling with severe sleepiness the week of Oct. 4. Her hands eventually regained most of their function but never full strength and she still (as of 3-7-21) has episodes of extreme hand weakness. Her sleepiness and fatigue also persist.
8 week old infant received the PENTACEL but it was not mixed, the liquid part was given and not the powder with no adverse event; 8 week old infant received the PENTACEL but it was not mixed, the liquid part was given and not the powder with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a other health professional and transmitted to Sanofi on 12-Jan-2021.  The case involved an 8 week old infant patient who received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (DTap Lot Number: U6842BA, expiration Date: 05-Jul-2021, ACTHIB Lot Number: UJ336AA, expiration Date: 05-Jul-2021, Carton Lot Number: UJ336AAA, expiration Date :2021-07-05) via intramuscular route in the right thigh for prophylactic vaccination on 12-Jan-2021, but it was not mixed, the liquid part was given and not the powder (product administration error and product preparation issue).  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE.  It was a case of actual medication error due to product administration error and inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  The reporter wanted to know the corrective measure to fix this and information about the patient next date to come.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or was to be held liable for the occurrence of this medication error.
Died; The initial case was missing the following minimum criteria: Reporter with no first-hand knowledge. Upon receipt of follow-up information on 13Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 (at the age of 66-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 for COVID-19 immunisation. The patient died on 11Jan2021; the cause of death was unknown. On 11Jan2021, the patient experienced cardiac arrest and breathless with outcome unknown. The patient was found pulseless and breathless 20 minutes following the vaccine administration. MD found no signs of anaphylaxis. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Died
10 MINS AFTER VACCINE PT FELT DIZZY, LIGHT HEADED, VERTIGO, ABDOMINAL PAIN, LEG NUMBNESS, HTN, CALLED 911, EMS ADVISED HOSPITAL
Pain at the injection site and radiate outward. It is oozing some type of fluid. She had COVID 5 weeks ago and the pain has continue since then.
Patient had a seizure within 15 minutes of vaccination. Ambulance came and took patient to hospital.
02/04/2021 chills, temperature, fatigue, body aches that lasted for 5 days and it resolved on its own.
Pt recvd 3 doses of Engerix-B & exp no medical problems or reactions; titer test reslt indicated no antibody;
Pt developed pain/tingling on LT rib/flank area 4/24/17; saw PCP 4/26/17 dx w/ shingles and started on acyclovir.
Passed out - within five minutes. I had one of my co-workers hold my Epi-pen for me just in case. All of a sudden, I woke up and was in ER. 150/105 and tachycardia and I had an oxygen level - started at 80 and they were able to get it up to 90 but that was only because I begged them to allow them to release me to go home. They had me right next to an area where people were COVID positive, and I wanted to leave. They released me because the doctors I work for were going to check on me anyway. I was there for about 8 hours though - they didn't like that my heart was racing. The next few days after, I felt terrible. It was - I had a low-grade fever and body aches until about that Tuesday. Recently, I don't feel 100% myself - I am more in pain and I've been getting these weird body aches where I feel like my left leg - I went to Hospital ER about a month ago for it. I couldn't move it at all. They told me it is nerve damage. I played soccer my entire life and I have had nerve conduction tests and it's not nerve damage. That pain started after I got the second dose but I just kind of shrugged it off for a while. Even now, I have to take sometimes - Tylenol or Motrin to have my leg feel better with the pain. I have to punch my leg because it feels like it is dead. I am walking along and then it feels like it "goes it dead" - I feel like I can't bend it to walk and then I almost falling to the ground because I don't realize that I've lost that ability. It is still happening. I also spoke to my OB/GYN - menstrual cycle has been out of control. It's like it went from a five day to two days and I barely have my period. There are 20 of us nurses that work together that all have the same complaint. My pap smear came back fine, and bloodwork came back fine.
This spontaneous report as received from a registered nurse (RN) refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored (temperature: 21.6 degrees Fahrenheit (F), time frame: 1 hour and 55 minutes; previous temperature excursion: 28 F, time frame: 6 hours and 15 minutes; total cumulative temperature and time: 28 F for 8 hours and 10 minutes; the vaccine was back in range) doses of M-M-R II, lot # K024035, expiration date: 26-NOV-2016 (status albumin, dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Breast feeding.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. In 2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Patient was still breastfeeding then after receiving booster.  Company comment: This is a spontaneous retrospective pregnancy case that reported the occurrence of Maternal exposure during pregnancy in a female patient of an unknown age who received an unspecified dose of mRNA-1273. Very limited information had been reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous retrospective pregnancy case that reported the occurrence of Maternal exposure during pregnancy in a female patient of an unknown age who received an unspecified dose of mRNA-1273. Very limited information had been reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
eczema; Initial information was received on 24-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves a patient (unknown age and unknown gender) who experienced eczema while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious eczema (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "When I stopped getting flu Vax my eczema stopped.5 years ago!".  It was unknown if patient's physician provided consent to be contacted   It was unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the event.  There will be no information available on batch number for this case.
Soreness at site initially, progressed soreness into left upper arm and Headache. After 24 hrs: left upper swollen, and left axilla, and L base of neck were sore. After 48 hrs: whole left arm swollen, lg goose egg size lumps were in my left axilla, left base of neck, both also had hard lymph nodes w/soreness. Start Medrol Dose pack 8/13/06, soreness gone by 8/17/06, but moderate edema noted still in base of neck 8/20/06.
30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose; This is a spontaneous report received from contactable reporter(s) (Physician).  A 30-year-old female patient (pregnant) received BNT162b2 (COMIRNATY), on 17May2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 22 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Dec2022. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious) with onset 17May2022, outcome "unknown", HYPOAESTHESIA (non-serious), NEURITIS (non-serious), PARAESTHESIA (non-serious), PAIN (non-serious) all with onset Jun2022, outcome "unknown" and all described as "30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose". The events "30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose" required physician office visit. Additional information: 30 y/o pregnant female developed left sided facial numbness and slight painful tingling (neuritis) 4-5 weeks after second vaccine dose. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My menstral cycle following vaccination I started to have symptoms of PMDD, I have now experienced symptoms of PMDD every cycle since. For 3 days before until 5 days after my period, 12 days to total, I am experiencing much worse SDHD symptoms where my stimulant medication does not work, I feel tired, weak, unable to focus, and much more impulsive and irritable.