chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 episodes in which she wanted to pass out; Ache; Flu like symptoms; Fever; A spontaneous report was received from a consumer, concerning herself, a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, aches, flu like symptoms and 2 episodes in which she wanted to pass out.  The patient's medical history was not provided. Concomitant product use was not provided.  On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# 007M20A]) intramuscularly for prophylaxis of COVID-19 infection.   On 08-Feb-2021, the patient reported that about 1 to 2 hours after receiving the vaccine, the patient reported that she "wanted to pass out" when she went grocery shopping. The patient also had fever, aches and flu-like symptoms. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events of fever, aches, flu like symptoms and "2 episodes in which she wanted to pass out", were considered resolved on an unspecified date in Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
with covid i just didn´t go; This case was reported by a consumer via Facebook interactive digital media and described the occurrence of covid-19 in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In March 2021, unknown after receiving Shingles vaccine, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was not recovered/not resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that he/she had one but did not go back and get the second shot and got them. The patient stated to get that second shot and the patient had the first one and kept saying he/she was going to get the second one but with covid the patient just did not go in and had a good case of them. The patient had them a little over two weeks and till the time of reporting was suffering with them.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR078798:same IDM - SD - 2nd report
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958806, 20210958566 and 20210959351. This case, from the Others is linked to 20210958716.
Received vaccine 11-17-14. Developed warm, red rash at site Rt. upper thigh overnight. No fever. Erythema 7 x 6", (R) upper outer thigh. Vaccine to Rt thigh-influenza, varicella.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 15th February 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mg. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX.  Additional information was reported as follows: The patient experienced pain at injection site for a period of 3 days and redness starting and subsiding, the third day. The batch number for SHINGRIX was unknown. For tolerance to next dose, refer case US2018GSK135762.
fainted; a little pain in arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting and pain in her arm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 04 Jan 2021, at approximately 09:00am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid prophylaxis of COVID-19 infection.    On 04 Jan 2021, after receiving the vaccine, the patient felt a little pain in her arm. On 05 Jan 2021, at approximately 19:00 the patient fainted after standing up. She hit her head on the floor and had a small bump on her head. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the events, fainting and pain in her arm, were considered unknown.; Reporter's Comments: This case concerns a 68-year-old female subject with who experienced a serious,  unexpected event of fainting and pain her arm. Her medical history and con meds were not provided. The fainting event occurred 1 day after the first dose of the mRNA-1273 study medication administration, after patient stood up, fainted, and hit her head on the floor and sustained a small bump on her head. Treatment for this event was not provided. Very limited information regarding the fainting event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a physician, concerning 6 patients whom a colleague indicated she had read about, who had been vaccinated with a dose of GARDASIL (date, route, lot # not reported), and subsequently developed "medium vesicle vasculitis."  No further details were reported.  The outcome of the events was not specified.  This is one of several reports received from the same source.  This is a hearsay report in the absence of unidentifiable patients.  Attempts are being made to verify the existence of the individual patients.
the patinet was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 09-DEC-2019, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) (albumin status: recombinant Human albumin (rHA)) lot # R026722, expiration date 17-MAR-2020 for prophylaxis (exact dose, dose number and route of administration were not provided). Sterile diluent used to reconstitute vaccine was properly stored.  The temperature excursion was from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (13.6 F) for 8 hours 14 minutes. There were no previous excursions reported. The digital data logger was involved.
Acute pulmonary embolism/two blood clots in lung; Chest pain; Pain over left arm; pain all over joints; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced CHEST PAIN (Chest pain). On 13-Apr-2021, the patient experienced PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Computerised tomogram: abnormal (abnormal) diagnosed acute pulmonary embolism.. Two blood clots in lung.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Description: The patient experienced pain over left arm, pain all over joints, nausea after vaccine administration. On 12 Apr2 021, the patient experienced chest pain and went to Emergency. Room where blood test and D-dimer was done. The treatment information included apixaban.  Company Comment:  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous case report was received from a registered nurse regarding unknown number of patients of unknown age and gender. No concurrent conditions and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with ROTATEQ stored outside of the recommended temperature range of 0.3 degree for 45 minutes (incorrect product storage) with a lot number # L037924 (expiry date: 22-JUN-2017), L013192 (expiry date: 19-JAN-2017), L013203 (expiry date: 28-JAN-2017). Concomitant medications of the patients were not reported. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
p/2nd dose of vax immed devel puffy face, lacrimation, swollen eye;DPH, Epi given & observed;
migraine; achy; temperature; nauseous; fatigue; insomnia; agitated; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 11:45 (Lot number: er8737) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa; "Generalized anxiety disorder" (unspecified if ongoing), notes: GAD; "Menopause" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies: steroids'" (unspecified if ongoing), notes: known allergies: steroids'. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "drug allergy", notes: known allergies: codeine; Trazodone, reaction(s): "drug allergy", notes: known allergies: trazodone. The following information was reported: MIGRAINE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "migraine"; PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "achy"; BODY TEMPERATURE ABNORMAL (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "temperature"; NAUSEA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "nauseous"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "fatigue"; INSOMNIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "insomnia"; AGITATION (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "agitated"; MYALGIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "muscle aches". The events "migraine", "achy", "temperature", "nauseous", "fatigue", "insomnia", "agitated" and "muscle aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, pain, body temperature abnormal, nausea, fatigue, insomnia, agitation, myalgia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with ZPAK and the patient was told to take excedrin, adevele had m and were unknown whether the patient was taking it.  No follow-up attempts are possible. No further information is expected.
Spiked a 103 fever, severe stomachache, has not had a bowel movement since the day before vaccination, which makes today 3 days without one.  First vaccine caused severe nausea and vomiting from 5minutes post injection and for the next 8-10 hours.
I had normal soreness, redness and slight swelling for a couple days after my first dose. One week after my first vaccine,  my (left) arm became very red, itchy and rashy, with swelling, spreading to an area about 4 inches in diameter.  This lasted for 4-5 days.
diarrhea; she slept all day; Joint pain; left ear pain; fever; nausea; headache; joint and muscle pain.; left jaw pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of jaw pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) .5 ml. On 22-JUL-2023, 1 days after receiving Shingrix, the patient experienced jaw pain (Verbatim: left jaw pain), ear pain (Verbatim: left ear pain), low grade fever (Verbatim: fever), nausea (Verbatim: nausea), headache (Verbatim: headache), muscle pain (Verbatim: joint and muscle pain.) and joint pain (Verbatim: Joint pain). On 23-JUL-2023, the patient experienced sleep excessive (Verbatim: she slept all day ). On 27-JUL-2023, the patient experienced diarrhea (Verbatim: diarrhea). The outcome of the jaw pain was resolved (duration 1 day) and the outcome of the ear pain, low grade fever, nausea, headache, muscle pain, diarrhea and joint pain were not resolved and the outcome of the sleep excessive was not reported.   It was unknown if the reporter considered the jaw pain, ear pain, low grade fever, nausea, headache, muscle pain, diarrhea, joint pain and sleep excessive to be related to Shingrix.     It was unknown if the company considered the jaw pain, ear pain, low grade fever, nausea, headache, muscle pain, diarrhea, joint pain and sleep excessive to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter was the patient and reported the next she experienced left jaw pain then resolved in one day.  The patient experienced left ear pain, low grade fever, nausea, severe headache, joint and muscle pain. None of which have resolved as of today (on the day of reporting).  Also today (on the day of reporting), she was having issues with diarrhea. Caller reported she slept all day on Sunday. The reporter gave permission to contact her HCP in this case.
I have not had my period since receiving the. first or second vaccination. I was originally expecting (healthy, regular periods) my period the first week of April. It's now May 1, 2021 and still nothing.
This spontaneous report as received from a nurse refers to an unspecified number of patients. On an unknown date the patients were vaccinated with ROTAEQ which were improperly stored (lot#, strength and dosage unknown) orally. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Received MMR/Varicella in right leg. 1-2 days after leg was red/raised at inject site with bumps. As of Jan. 10, 2015 symptoms continue to look the same.
Shortly after vaccination the pt was very anxious and said she felt dizzy.  Pt never did past out but was very dizzy and had blurred vision.  We laid the pt down and elevated her feet and she was much better.  Mom called EMS and the pt was monitored and recovered.  I spoke with the mom  Sat night and Sun and she was  feeling fine.  Pt returned on 6/26/21 for second dose and had no reaction.
The first signs and symptoms that I noticed were redness, swelling and tracking in his thigh. The redness had warmth to it and continued to grow over a week long period and got to the size of a golf ball in his thigh. He still has a knot and discoloration in his thigh over six months later. Since this vaccine he has started having life threatening food allergies and has been hospitalized twice for that. He has also started losing blood, having bowel disorders, now has an immune deficiency, is constantly sick. He has regressed and made no language progression in over six months. He is an incredibly sick child and was not prior to these vaccinations on 3/22/2016.
Employee reported sudden onset of pain across upper chest and shoulders that began 5-6 hrs after his Anthrax vaccination. Discomfort lasted for several hours. States this happened after his 2nd and 3rd Anthrax shot. Did not seek medical attention. After second episode, he took a Benadryl and went to bed. Both occasions symptoms were totally resolved following morning.
Red swollen itchy patch or hive at injection site starting on day 8  after the first dose
Pt reported mild chest tightness, but states she did not take medications for BP this morning 0953: BP 127/66, HR 65; O2 96%, Temp 36.5C; Denied need for higher level of care Reports she will take BP meds with hydration once she leaves hospital vaccine clinic Left @1020 from hospital symptom free
Presented to the Emergency Department for shortness of breath with rapid heart rate.  azithromycin/ceftriaxone.   --Decadron --vitamin-C/zinc                                                                                                                                              3-4 L of supplemental oxygen via nasal cannula
Information has been received from a consumer concerning an 11 year old female with no pertinent medical history who on an unspecified date was vaccinated with a 0.5 ml first dose of Gardasil.  On 22-SEP-2007 the patient was vaccinated with a second dose of Gardasil.  There was no concomitant medication.  On 22-SEP-2007 the patient fainted.  There was no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  On 22-SEP-2007 the patient recovered.  Additional information has been requested.
This spontaneous report was received from a medical assistant via a company representative concerning a 12 month old patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 03-MAY-2017, the patient was vaccinated with a dose of VAQTA 0.5 ml vial, 0.4 ml, lot # N003194, expiration date: 28-OCT-2017, as prophylaxis (Route of administration was not reported). It was reported that the patient only received 0.4 ml of VAQTA rather than the full 0.5 ml volume, due to the volume of the vial was less than 0.5 ml. The patient had not demonstrated any adverse effects. A product quality complaint was involved. Additional information has been requested.
Patient received a Covid 19 Vaccine made by Moderna on 4/28/21. On Friday  May 1st ,Patient started having  stomach cramps. Pt started menstruation on Saturday with full flow. Patient has continued to have stomach cramps and low back pain similar to when she gets her period since Saturday. However she hasn't bled starting Sunday.
I was breastfeeding and the day after the shot I was no longer producing breast milk. I was completely dry no longer producing milk. Before I was producing 18oz a day.
Approximately 2 weeks after receiving my 2nd shot I started experiencing short pulses at the top of my head in various spots. I did not have a headache. Then I experienced neuropathy symptoms - itching and burning at the top of my head. This condition lasted for approximately 4 months - till the end of July. The condition was reported to my Primary Care Physician on 5/25/21. All symptoms have disappeared with no long term adverse effects.
Heart palpitations - s.o.b approx 9-24-09 - saw cardiologist - medication headache dizziness - confusion - unsteady gait.  To start physical therapy 10-27-09 for weakness right side 11/10/09 DC summary and medical records received for 10/24/09. DX: gait disturbance, mild deficits in short term memory, HA. Pt admitted from ER w/ c/o lightheadedness, gait disturbance, cognitive deficits. Pt. declined most care options including rehab and additional diagnostics. Assessment: lightheadedness (+), unsteady gait, memory impairment.
Pt developed local swelling, erythema and single vesicle at site of injection in right thigh.
to ED after being found down at home,+ COVID pneumonia, required intubation, has severe metabolic/resp acidosis, on pressors s/p possible STEMI, pt made DNR and expired in hospital. TX: maxipime, bicarb, Vanc.
Information has been received from a physician concerning a 19 year old female with penicillin allergy and no pertinent medical history, who on an unspecified date was vaccinated with the third dose of GARDASIL. Concomitant therapy included YAZ. On 05-JAN-2010 the patient developed a 5cm indurated red raised lump, the size of a lacrosse ball at the injection site. There were no labs or diagnostic tests performed. It was unknown if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
ON 3/31 PATIENT STARTED FEELING UNWELL WITH FEVER, CHILLS AND PATIENT COULD NOT GET WARM. SHE JUST WANTED TO LAY DOWN BUT DID NOT AND FELT UNWELL OFF AND ON AND THROUGHOUT THE DAY. AFTER MIDNIGHT HER HANDS WERE BOTH TINGLING AND THAT'S WHAT WOKE HER UP. BOTH HANDS FROM THE WRIST DOWN TO THE FINGERS SHE FELT NUMBNESS AND TINGLING WHICH LASTED NO MORE THAN 30 MINUTES. NEXT DAY SHE FELT LETHARGIC WITHOUT ANY CHILLS OR NUMBNESS. ALL SIDE EFFECTS HAD SUBSIDED.
I experienced extreme swelling, soreness, and a rash that was 9 to 10 inches round in diameter. I had a tele-visit with my doctor who recommend putting a cold compress on my arm and it took approximately 1 week for the symptoms to subside. I also had dizziness and fatigue which also went away.