chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 79 year old female consumer (reporting on herself). The patient had current conditions including blood pressure issues, chronic bronchitis, chronic obstructive pulmonary disease (COPD) with emphysema and glaucoma. The patient did not have any drug reaction allergy. It was reported that about five years ago, approximately in May 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (1 dose, route unspecified). Concomitant therapy included minerals (unspecified), CENTRUM SILVER (OTC product), calcium carbonate, CALTRATE 600 PLUS VITAMIN D (OTC product), ibuprofen, oxygen, fluticasone propionate, ADVAIR, SPIRIVA, albuterol, gabapentin, lisinopril, baby aspirin (OTC product) self prescribed, hydrochlorothiazide HGTZ and TRUSOPT. On or about 03-APR-2013, the patient broke out with shingles. She said at first she felt as if she was getting the flu and this lasted a day or two. Finally she felt feverish and she went to bed and slept 19 hours straight and when she woke up she noticed blisters erupting on the left side of her face above her eyebrow. She said she went to the doctor about 4 days later. The patient described the having itching, painful blisters in the left side of her face and scalp and on around her left eye. She also said that since this occurred she had been having her feet swelling as well as her ankles. The patient also said that for the past few weeks she does not felt as "sharp" as she usually did. She claimed she was having a hard time focusing on what she was saying and seemed forgetful. The patient sought medical attention and was given acyclovir, NEURONTIN, ZADITOR, erythromycin, VICODEN and tramadol as a treatment for adverse events. Laboratory diagnostic studies were not performed recently. At the time of the report the flu symptoms were recovered, the shingles, swelling of ankles and feet were reported as recovering. The event hard time focusing on what she was saying and seemed forgetful were reported as not recovered. Additional information has been requested.
left breast is bigger than the right; Stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure; armpit over to chest side is swollen; swollen under left armpit; left arm soreness; left side pain toward her back feeling like someone is pushing toward the inside; This is a spontaneous report from a contactable consumer (patient) reported that:   A 37-year-old female consumer (patient) received bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: EW0179) via an unspecified route of administration, administered in left arm on 23Jul2021 (at the age of 37 years old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On23Jul2021, the patient had experienced left arm soreness. On25Jul2021, the patient had experienced swollen under left armpit. On 26Jul2021, the patient had experienced armpit over to chest side is swollen and Stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure. On27Jul2021, the patient had experienced left breast is bigger than the right. Treatment Patient Stated that she drank Tylenol for the left arm soreness. At the time of reporting, the events swollen under left armpit, left breast is bigger than the right and stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure were not recovered. The events armpit over to chest side is swollen and left arm soreness were recovering.   Follow-up attempts are completed. No further information is expected.
MIGRAINE HEADACHE; LITTLE DIZZINESS; This spontaneous report received from a consumer concerned a 62 year old female. 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, batch number: 2062A21A expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the subject experienced migraine headache. On 03-AUG-2021, the subject experienced little dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little dizziness on 03-AUG-2021, and had not recovered from migraine headache. This report was non-serious.
received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication  was reported. No treatment medication  was reported.   This case was linked to MOD-2021-363183, MOD-2021-363304, MOD-2021-363329, MOD-2021-363331, MOD-2021-363389, MOD-2021-363404, MOD-2021-363411, MOD-2021-363418, MOD-2021-363421, MOD-2021-363460, MOD-2021-363485, MOD-2021-363557, MOD-2021-363576 (Patient Link).
Overdose; Administration of two diluents of the Menveo vaccine/on the same day; Administration of two diluents of the Menveo vaccine/on the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 3rd May 2021, the patient received Menveo (intramuscular). On 3rd May 2021, unknown after receiving Menveo, the patient experienced overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received two diluents of the Menveo vaccine in the left deltoid, which led to inappropriate preparation of medication, overdose of MenCWY-135 component and inappropriate dose of vaccine administered as did not received MenA component. No further events were reported.
Approx 12 after shot I woke up feeling very ill and nauseous. As I walked to the restroom to vomit I lost 100% of my vision, I became very disoriented and had the loudest screeching in both ears. I screamed for my husband and I caught me as I was taken to the floor with no mobility. The episode last several minutes before he was able to move me back to bed. I had severe sweating and ear ringing. As I report this I still have a lingering brain fog and ear ringing.  I reported it to my physician and told to go to the ER if any reoccurrence of reaction.
Patient presented with profound weakness of upper extremities and left leg. She was unable to lift her right arm off of the bed. She had severe tenderness at the site of injection in her R deltoid. Labs were notable for acute tubular necrosis secondary to rhabdomyolysis. Also found to have sepsis of unknown origin at the hospital, presenting with hypotension and an elevated WBC and inflammatory markers. Weakness improved 5 days after vaccination with a decrease in inflammatory markers. Patient received cefepime, vancomycin, and metronidazole for 4 days, then was transitioned to ceftriaxone and minocycline. She was discharged on minocycline and cefpodoxime to take to finish a 10 day total course. Following episode of vaccine induced myositis and weakness, she became physically weak due to being bedbound in the hospital requiring placement in sub acute rehab following discharge.
I am experiencing Severe Depression, severe Anxiety, and  Suicidal ideation. I do not have insurance so I am not able to seek help. I was in perfect mental health before taking the vaccine. Today is my 3rd day and I am very scared of what is going on with me as I am having constant suicidal thoughts and constant crying spells with no apparent reason.  On the 3rd day, I am experiencing chest pressure , dizziness and palpitations.  But the depression and the suicidal ideation is the major symptoms right now.
hives, mostly on feet but spreading to legs and arms. given shot of decadron and suggested to use otc antihistamines and ointments. hives started on right foot between ankle and heel Tuesday night 11/22, then spread to toes and outside of left foot. by Thursday, hives were 80% covering tops of both feet and spreading up legs. some on back of knees, backs of upper arm, trunk.
Elevated heart rate within 2 minutes of vaccination, lasting approximately 10 minutes, then subsiding
Pt recvd 1st dose of Hep B vax on 28APR92 & 8 hrs later devel fever, body aches, muscle weakness, chills, tachycardia (from 80 to 103 beats/minute) & pain @ inject site; pt recovered p/3 days; no further details were provided;
Patient was diagnosed with an acute, extensive left leg deep vein thrombosis (DVT) on 5/26/2022; less than 2 weeks after a Moderna COVID-19 vaccine booster.
Patient received expired vaccine (6/30/21) and came back on 10/25/21 to receive new Fluzone
Received Hep A vaccine on 8-4-08, developed rash at site of inoculation - erythematous, not painful or itchy but 5"x5 1/2" in diameter.  Treatment: BENADRYL, ice/cold compress, f/u in 1 day.
Received phone call from mother stating child was broken out in whelps, swollen hands, and running low grade temp. Injection site was clear with no redness or inflammation. PCP thinks it is from the vaccine and ordered DECADRON and BENADRYL.
Pt recvd shot about 10AM & started screaming about 3PM until about 8PM; pt had a delirious look in eyes;
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received SHINGRIX (batch number 75GJ5, expiry date 2nd February 2021) and (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 28th June 2018 01:00, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist administered SHINGRIX to a co-worker and the patient experienced shingles 5 days after the SHINGRIX vaccine. The patient received a SHINGRIX vaccine around 1 to 2:00 PM and the shingles presented in her buttock's crack. The patient was prescribed acyclovir 800 mg 5 times per day for 7 days on 6th July 2018.
Intense headache within a couple hours, typical nausea lasting approx 48 hours.  On day 5, severe nausea with the feeling I was going to pass out or faint.  Typical symptoms of light headedness and tingling sensation that last approx 30 minutes.  Sat down and drank a bottle of water with a light snack (same as if blood donation procedure).  On day 7 hives and a rash covered the injection spot, along with moving down approx 3 inches down from the site and about 2 inches wide, along with, muscle pain when touched in the armpit traveling almost the same distance as the rash on the outside of the arm .
Patient received the second dose of Moderna when he was 17. No adverse events or reactions was reported by the patient.
Information has been received from a nurse referring to a patient of unknown age. Concomitant medication, medical history and concurrent condition were not reported. The reporter stated that expired VARIVAX (Merck) (lot # J004164, Exp 8-APR-2015) was administered to patient on 09-JUL-2015. No adverse effects reported. Additional information has been requested.
1.Ear (left)tinnitus strted after 1 week - 10 days after 2 nd dose.  Sometimes pain , burning in ear. Consulted ENT, said tinnitus no visible problem with ear. Audio test normal. But tinnitus is still bothering.  2. Wisdom tooth pain, got 2 teeth extracted in July 2021 from left side. Had no tooth problem before. 3. Menstruation suddenly stopped, just had light periods after 2nd dose.  Had always had regular cycle. And, nothing after that. waiting for gynae appointmnet.
I had shots for the flu, Hep, Tetanus and MMR.  Three shots in right arm and one in left arm.  Extreme pain continued in right arm/shoulder.  Can not lift heavy items, very difficult to dry hair, get dressed, pick up groceries.  Arm "pops" or "cracks" when moved to certain positions.  Difficult to sleep at night - continuous throbbing pain, starting in arm going into shoulder, back, neck and sometime leg.
Right arm patient received TDaP and MENACTRA. Developed swelling pain and redness after shot 20 x 10 inches. Seen 2 days later with problems. No chest pain.
BURNING SENSATION ON SITE AND FELT LIKE HARD TO SWALLOW, BENADRYL GIVEN by ONSITE EMT. SX SUBSIDED IN 10 MINUTES.
arm swelled up; still hard and tender to touch; difficulty breathing; felt sick for two days; this is third day and feels a bit better; arm swelled up; still hard and tender to touch; joint pain; tried getting out of bed but body didn't want to move; chills like crazy; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up; still hard and tender to touch), DYSPNOEA (difficulty breathing), MALAISE (felt sick for two days; this is third day and feels a bit better), TENDERNESS (arm swelled up; still hard and tender to touch) and ARTHRALGIA (joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up; still hard and tender to touch), DYSPNOEA (difficulty breathing), MALAISE (felt sick for two days; this is third day and feels a bit better), TENDERNESS (arm swelled up; still hard and tender to touch), ARTHRALGIA (joint pain), FATIGUE (tried getting out of bed but body didn't want to move), CHILLS (chills like crazy) and MYALGIA (muscle pain). The patient was treated with FENTANYL CITRATE (NARCO) for Back pain, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelled up; still hard and tender to touch), DYSPNOEA (difficulty breathing), MALAISE (felt sick for two days; this is third day and feels a bit better), TENDERNESS (arm swelled up; still hard and tender to touch), ARTHRALGIA (joint pain), FATIGUE (tried getting out of bed but body didn't want to move), CHILLS (chills like crazy) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient take had to use her inhaler couple of times   This case was linked to MOD21-069274 (E2B Linked Report).; Sender's Comments:  MOD21-069274:
My daughter had her 3rd GARDASIL vaccine in Sept. She was a very healthy young lady, she went to take a shower and died. Autopsy report states undermined death. There was no sign of trauma to the body to indicate a fall. She had pointed the shower head away from her and she got down on her knees and put her head on the edge of the tub and passed away. This has been a living nightmare for her family. She is not the only one to have had problems and death from this vaccine. Please I beg you to please take it off until it can be further tested. -not tested long enough to begin with- There will be others that will die if the cause is not found. 1/29/09-records received-COD-undetermined.   6/26/09 Medical records received DOS 10/29/07 to 1/14/08. Assessment: Immunizations and Contraceptive Management. HPV#1 10/29/07 LA Merck Lot# 1062U
4/3/21  Fever 101.6 F, minor headache, moderate fatigue, slight throat discomfort 4/4/21 adverse reaction gone
1 1/2 after vaccines given, child developed a generalized pustule rash, worse to upper legs and trunk. On an off fever-a high temp of 103.2. Current temp 97 degrees. Mother gave child MOTRIN, red, warm, hard knot to (R) upper leg injection site 20mm x 10mm.
headache that started the same day after vaccination.  received vaccine early afternoon and  had onset headache in the evening. child might go to ER for headache relief as she has tried multiple  options without relief.
Developed rash on right arm from elbow to wrist. Went to MD three times, possible shingles diagnosis. Has healed well.
Sore throat, fever headache after receiving second dose of HPV, fever of 101.3, abdominal pain leg pain.
Patient was seen two days after receiving the varicella vaccine.  The complaint at the time was unable to walk and balance difficulties.  There was phone follow-up in the afternoon with some improvement and again phone follow up the next day with increased improvement.
Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced HEADACHE (Terrible headache). At the time of the report, HEADACHE (Terrible headache) outcome was unknown.            No concomitant and treatment medication information was reported. Patient wanted to know if he could take aspirin instead of Tylenol for a terrible headache he was experiencing after receiving the second dose of the vaccine yesterday, 09MAY2021. The caller declined to share any additional information.
Got HEPLISAV-B then got ENGERIX-B; Initial Report Received on 19-Mar-2021  A pharmacist reported that a 25 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then ENGERIX-B one month later.  No relevant medical history or allergies was reported.    No relevant concomitant medications were reported.  On 18-Feb-2021, the patient received a dose of HEPLISAV-B (Lot # 934601, expiration date 16-Mar-2022 and NDC # 803373837456), intramuscularly and the site of administration not reported.   On 18-Mar-2021, 29 days after having been vaccinated with HEPLISAV-B, the patient went to a different pharmacy and got ENGERIX-B (Lot # and expiration date unavailable, NDC # 581600821-52). No adverse reactions to either injection was reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Felt slight swelling in left armpit exactly one week after the vaccine (3/25). On 3/26 swelling was mildly painful and the place of original shot was red and slightly raised.
This spontaneous report was received from a licensed practiced nurse refers to a 57 year old male patient. On 05-FEB-2013, the patient was vaccinated with first dose of RECOMBIOVAX HB, (lot number, expiry date and route was not reported). On 06-MAR-2013, the patient was vaccinated with second dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Burning in upper right leg/thigh started just under 2 hours post injection. Over the coming  days the burning spread to the other leg and then through out my entire body.  Numbness and tingling started in my hands and feet and lips.  Also started to have shooting pains in my lower back. It  seems things worsen every 3 to 4 days.
very fast heart beat; This is a spontaneous report from a contactable consumer or other non hcp. An 85 year old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: FN5318) via an unspecified route of administration, administered in arm left on 01Feb2021 at 15:00 (at the age of 84-years-old) as 1st dose, single dose for covid-19 immunization. The second dose was schedule on 22Feb2021 at 12:40. Medical history included hypertension, arthritis. Patient stated that She had arthritis in the knees, 1 knee was worse than the other. She does try to exercise the 1 knee, she had DVD's and stuff she does, aortic aneurysm from 2017 to an unknown date. Concomitant medications were not reported. On 01Feb2021 19:30 the patient experienced very fast heartbeat. Patient clarified that when the fast heartbeat started, she actually took that one pill, it was Benazepril 20 mg, it's a generic for Lotensin. On 01Feb2021 the patient underwent lab tests and procedures which included echocardiogram: unknown results on heart rate: fast. The outcome of the event was recovered on 01Feb2021.  Follow-up(16Apr2021): Follow-up attempts are completed. No further information is expected.
He had two grand mal seizures after the Varicella Vaccine. One on 1/12/15 & another on 1/29/15. He has had no seizures since the adverse reaction from the vaccine.
Initial symptoms of pain behind the thigh, calf  and foot swelling, area warm to the touch, racing and abnormal heart beat.
Rec'd Sat. 3:10 PM, woke up next day w/temp of 101.3, red itchy painful red welt oval about 5 in long and 3 in wide, painfully joints, achy muscles, bad muscle spasms in lower back mostly on the right side, headache, no appetite, slept most of the day for 3 days, extremely weak and couldn't function. I missed 1 day of work, it was a weekend and we were off on Monday, I missed Tuesday. I started feeling better with some strength, I ate, showered, had a headache and the red welt on my arm still exists, is itchy, less painful. So everything lasted about 3 days.
bad congestion; cough; really sick; felt horrible/feeling horrible; chills; nausea; throwing up; This is a spontaneous report from a contactable consumer (patient). The 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 27Mar2021 (Lot Number: EL3302) as Single dose for covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported.  The patient experienced chills and nausea, both on 28Mar2021 with outcome of recovered on 29Mar2021, and throwing up on 28Mar2021 with outcome of recovered on 28Mar2021, bad congestion and cough both on 29Mar2021 with outcome of recovering , really sick and felt horrible both on 29Mar2021 with outcome of unknown. Lab data included Covid test negative on 05Apr2021. The clinical course was reported as follows: On 27Mar2021 she got her first dose and her second dose was on Saturday 17Apr2021. She had some side effects, chills, nausea, throwing up, which she guesses was normal. 2 days after that, she got a cough, and was really congested, and felt horrible. She went to urgent care for a rapid test which came back negative. She says the doctor there, told her a lot of those test don't come back accurate.  No follow-up attempts are needed. No further information is expected.