chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I used the  syringe provided by the ancillary kit (it consists of a syringe barrel and separate needle) to draw up the vaccine.  I tightened the needle to the syringe as usual.  When I went to inject the solution into the patient's arm, approximately 0.1ml went into the arm and then the needle wouldn't push.  I pushed slightly harder than I usually need to, in attempt to inject the remaining contents,  and the liquid squeezed out between the barrel of the syringe and dripped down the patient's arm.  Because the patient  did not receive  even close to 1/2 dose, the CDC guidelines recommend to redo the dose.  The patient consented to receiving  the dose and the dose was administered.  No adverse reaction within 2 hours of the injection.
Feels warm though no fever.  Edema in hands / feet skin all over body was sensitive to touch.  Steroids started 7/28/09 and ZANTAC. 9/1/09 PCP records received for 7/27/09 to 7/29/09. WCC 7/27/09 with vax given.  Returned 7/28/09 with c/o allergic reaction to Gardasil.  Pt c/o dyspnea, pain and edema in hands and feet, chest pain,feels hot despite normal temp.  Also nausea, vomiting and diarrhea noted in ROS.  Pain with palpation to extremities. 7/29/09 reports knot at injection site. Skin improved. Tx: Benadryl and NSAIDS. 1/6/10:  PCP Record received for date of service 7/27/09.  Hx of Bee sting allergy, epi pen refill given.
The day after receiving my 2nd vaccination, I was very sick with a high fever, headache, body aches, chest congestion, and generally just feeling bad. I also developed dizziness within days of my second injection and it has continued to persist and is getting worse. Sometimes I struggle to stand because of dizziness. I am also having extreme night sweats and very vivid dreams. I have never experienced these symptoms before. I got a double ear infection (never had an ear infection in my life) and strep (have not had in 20years) at the same time a couple of weeks ago.
HYPOTENSION  4/29/2022,  6/2/2022,  12/30/2022 --  RECURRENCE OF SAME SYMPTOMS
LOSING HAIR OF HAIR, ARMS AND LEGS; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 165 pounds, and height was not reported. The patient's concurrent conditions included no smoking, and no alcohol use, and other pre-existing medical conditions included medical history none as per patient. stated taking prostate pills but denies any prostate issues. no known allergies and drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20CA21A, and expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-JUN-2021, the subject experienced losing hair of hair, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from losing hair of hair, arms and legs. This report was non-serious.
Pt. had injection of H1N1 on 12-9-09. On 12-10-09 felt drowsy and sleepy. Could not awaken child well from nap - couldn't walk well - was examined by EMT and was told child was okay - finished our day at school. No further problems.
Pt started with headache, subjective fever and slight redness at site 2-3 hrs after injection. Presented in office 48 hrs after injection with 3x3 inch redness and 2 x 2 inch hardness. Grandmother states headache and fever x 48 hrs. No fever at time of office visit. Treatment-BENADRYL and MOTRIN/TYLENOL.
It was tender, but not painful or itchy; rash has persisted on her arm; Arm is still red where she got the shot; Hives on the left side of her face and left arm; Had very little food; Slept all day Thursday; feeling sick; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick), HYPOPHAGIA (Had very little food), SOMNOLENCE (Slept all day Thursday), URTICARIA (Hives on the left side of her face and left arm) and VACCINATION SITE PAIN (It was tender, but not painful or itchy) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot in August 2023 and RSV vaccine on 19-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot and RSV vaccine. Concurrent medical conditions included Kidney failure (stage 3 Kidney failure).    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 27-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MALAISE (feeling sick). On 28-Sep-2023, the patient experienced HYPOPHAGIA (Had very little food) and SOMNOLENCE (Slept all day Thursday). On 30-Sep-2023, the patient experienced URTICARIA (Hives on the left side of her face and left arm). On an unknown date, the patient experienced VACCINATION SITE PAIN (It was tender, but not painful or itchy), RASH (rash has persisted on her arm) and VACCINATION SITE ERYTHEMA (Arm is still red where she got the shot). At the time of the report, MALAISE (feeling sick), HYPOPHAGIA (Had very little food), SOMNOLENCE (Slept all day Thursday), URTICARIA (Hives on the left side of her face and left arm) and VACCINATION SITE PAIN (It was tender, but not painful or itchy) outcome was unknown and RASH (rash has persisted on her arm) and VACCINATION SITE ERYTHEMA (Arm is still red where she got the shot) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's other Moderna covid-19 vaccination details included: First dose on 03-Feb-2021 with lot number 030L20A, second dose on 04-Mar-2021 with lot number 030L20A, Third dose on 05-Nov-2021 with lot number 022M20A, Fourth dose on 20-Oct-2022 with lot number 031F21A. Patient's vaccination site was tender, but not painful or itchy. Patient queried that if hives a reported side effect with the Moderna Vaccine. Treatment information was not provided.
Red Eyes Doctor treated me for pink  I was given eye drops but it didn't work Went back to the Doctor, diagnosed as Conjunctivitis given eye drops and told to take Claritin and  Zyrtec. Still isn't working my eyes are red now.
left arm into neck pain, headache, low grade fever, nausea, body aches,  treated with rest  01/07/ still has headache
I have sensory neuropathy a that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds.; Headache the following three days and still having the increased pain and sweats.; I have sensory neuropathy a that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds.; I have been having sweat break outs day and night.; Headache the following three days and still having; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 09Apr2021 at 12:00 (Lot Number: EW0158) (at the age of 65-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included peripheral sensory neuropathy (I have sensory neuropathy that causes muscle and joint pain on a daily basis), diverticulitis, colitis, Raynaud's phenomenon, Sjogren's syndrome, gastrooesophageal reflux disease (GERD), all from an unknown date and unknown if ongoing.  The patient had known allergies: Sulfur, aspirin, cevimeline. The patient did not experience COVID-19 before vaccination. The patient did not receive any vaccination in four weeks prior COVID-19 vaccine. Concomitant medications included pregabalin (LYRICA); hydrocodone; pantoprazole and mirabegron (MYRBETRIQ), all concomitants taken for an unspecified indication, start and stop date were not reported. The patient reported that: "I have sensory neuropathy that causes muscle and joint pain on a daily basis. Hours after getting the Pfizer vaccine (on 09Apr2021) my pain became unbearable even after taking my pain meds. I have been having sweat break outs day and night. Headache the following three days and still having the increased pain and sweats. The events were serious, disabling. The patient outcome of the events was not recovered.
Left Chest Pain that was sharp for about 5 minutes.  Blood pressure initially was 196/96.  Blood pressure came down, and I completed a full day of seeing patients.  I then reported in the evening to the ER for testing.  No Heart Attack or Blood Clot was diagnosed.  So, this was musculoskeletal pain at the left costochondral region.
Red, hot, swollen, tender, hard to touch able to move arm to full capacity- but overall ROM is still very good.
On Friday June 11 I woke up with itching hands; as the day went on the condition worsened; I applied Aveeno and Benadryl cream; Saturday June 12th I went to urgent care and received a Steroid shot which did help the rash and hives. On Sunday June 13th I noticed my hands starting to hurt ; by Monday the the pain was severe; I saw my family Dr on Tuesday June15th on he prescribed oral steroids. Wednesday the pain had moved to my shoulders and hands where it continues. The pain is not as severe but it still hurts to move my shoulder or to grip things with my hands.
I developed a minor headache before going to bed at 11:00 p.m. The bedroom temperature was a comfortable 71 degrees but I suddenly developed chills and could not warm myself, even with additional bedding. The chills lasted about an hour and then I got up to get more bedding as I was uncomfortably cold. Once up, my entire body shook violently with chills including chattering teeth. I've never experienced shivering so extreme involving my entire body. I returned to bed under even more bedding and the shivering/chills eventually subsided after about an additional hour. My other symptoms included worsening headache and nausea. After a poor night's sleep, the chills were gone but I was left with a headache and mild nausea.
This case was reported by a consumer via out of hour services and described the occurrence of adverse event in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. No additional information was reported. Follow up attempt was made to call patient.
2hrs p/vax, pt started to have soreness in shoulder joint 2 hrs p/vax; around 630-7PM began to have difficulty breathing; took 2 DPH & relief occured 30 mins later; slept-no problems; awoke w/feeling of itching around abdo;no rash noted.
This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received DTPa vaccine. In December 2014, the patient received DTaP vaccine. On an unknown date, less than a month after receiving DTaP vaccine, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown. It was unknown if the patient considered the muscle pain to be related to DTap vaccine. Additional information received: In December 2014 the patient received a tdap vaccine, which caused a extreme reaction. Her muscles became extremely painful and not working. Patient notifyed the company of this reaction in January 2015. Then, she went to the Doctors 4 times trying to figure out why and what this is doing to her body. Her 5th appointment was coming up.
Patient remembers pain during administration. Overnight, experienced muscle spasm, shakes and fever. Experienced (L) shoulder pain for one month. On 11/6/17, visited doctor and discovered possibly caused by SIRVA - shoulder injury related to vaccine administration. Left shoulder pain - MD has ordered Xray/MRI for further eval.
Hypothermia (usually 91.2-95.6F), memory and cognitive loss, total loss of ability to mentally visualise, dizziness, light headedness, inability to concentrate, lethargy, low energy,, extreme tiredness, numbness on left side of face and now the vision in my left eye is ?bad?; difficult to describe. This started 40 minutes after the first vaccine, peaked within two days and has been constant for over two months now, though the eye problems have been within the last week and are getting worse. It feels like a bad hangover mixed with a low grade ?flu that has been constant and shows no sign of diminishing. PLEASE help me, I?m not sure how much more I can take of this
Strange headaches particularly when in prone or inverted positions. Feeling of pressure in head, eyes, sinuses. Occurred in the week following my second dose and again 2 weeks later. I can't know if it was related to the vaccine.
I have had intermittent chest pressure and minor arrhythmias with an intensification of arthritic pain and fatigue.  The fatigue is abating.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "intracranial hypertension" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient received no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid, from 27Mar2023 to 01Apr2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300147677 same patient, different drug/event;
Headache, Myalgia, Fever, CoughWheeze, Fatigue Narrative:
12/18/2020 morning I started to have runny nose, achy 'like coming down with a cold'. Late evening and early morning 12/19/2020 tender lymphnodes, same side of vaccination. As of 12/20/2020 barely palpable anymore. Temperature was normal. I took ibuprofren and tylenol; 12/18-12/19.  Congested, nasal drip ' 48 hours of feeling worn down and achy'.  Flu shot in October 2020
No adverse effects reported; one dose of an improperly stored vaccine, VARIVAX, was administered to one patient; VARIVAX / assistant confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 11-SEP-2019, the patient was vaccinated with improperly stored vaccine of varicella virus vaccine live (oka/merck)(VARIVAX)0.5 ml, once, intramuscularly, lot # S002877, expiration date 29-JAN-2021, for prophylaxis (strength, lot#, expiration date were not reported). VARIVAX was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT), possible lot # S000130 expiration date reported as 23-AUG-2021.  The temperature excursion was of 8.1 Fahrenheit degrees (°F), for 20 minutes. However, a previous temperature excursion of 8.1 °F for 17 minutes, and 9.5°F for 21 minutes were also reported. A digital data logger was involved. No adverse effects were reported.
Excess gas after 2 hours of injection and nausea.  20 hours - lower abdominal pain  with feeling of having to use the bathroom
His wife had a kidney transplant and the vaccine did not work for her; This spontaneous case was reported by a consumer and describes the occurrence of RENAL TRANSPLANT (His wife had a kidney transplant and the vaccine did not work for her) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL TRANSPLANT (His wife had a kidney transplant and the vaccine did not work for her). At the time of the report, RENAL TRANSPLANT (His wife had a kidney transplant and the vaccine did not work for her) outcome was unknown.            No concomitant medication was reported. It was reported that the patient had a kidney transplant and the vaccine did not work for her, so they are looking for the studies where people who have get immunized and they had a negative effect.  No treatment medication was reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Swelling and erythema approx 4 cm at injection site - left upper arm.
itching; hives; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183), via an unspecified route of administration on 11May2021 at 15:00 (at the age of 67-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing , blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included doxazosin mesilate taken for an unspecified indication, start and stop date were not reported, amlodipine besilate taken for an unspecified indication, start and stop date were not reported, lisinopril taken for an unspecified indication, start and stop date were not reported, rosuvastatin calcium taken for an unspecified indication, start and stop date were not reported, acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported, bioflavonoids nos, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS) taken for an unspecified indication, start and stop date were not reported. On 12May2021, the patient experienced itching, hives. She had the same reaction to sulfa but this one was much worse. Patient was asking if there was anything in the vaccine that she was allergic to. The patient was scheduled for the second dose on 01Jun2021. Therapeutic measures were taken as a result of events included benadryl. The outcome of the events were resolving.   Follow-Up (09Jul2021): Follow-up attempts are completed. No further information is expected.
Extreme bone pain, sacrum, sternum, and everywhere , fever, headache body rash torso
sinusitis (allergies); pain at injection (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinusitis (allergies)) and INJECTION SITE PAIN (pain at injection (left) arm) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection (left) arm). On 02-Mar-2021, the patient experienced SINUSITIS (sinusitis (allergies)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Sinusitis, at an unspecified dose and frequency. On 14-Feb-2021, INJECTION SITE PAIN (pain at injection (left) arm) had resolved. At the time of the report, SINUSITIS (sinusitis (allergies)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
On May 8, 2021 I started experiencing heartburn/chest tightness that lasted about 3 days. I had never really had heartburn before so it was noteworthy. As the day progressed, I considered going to the doctor but did not. I called my father for advice on what medication he uses for heartburn.  I ended up buying 3 types of medication (Tums, famotidine tablets, and Alka-Seltzer. I can confirm the date of purchase by the date and amount paid.
Information has been received from a physician regarding a 59 year old female whose husband was vaccinated on 19 JAN 2008 with a 0.65 ml of ZOSTAVAX (Lot # "0179U"), and about one week later, on approximately 26 JAN 2008, she developed painful, dermatomal vesicular eruptions of the right buttock and right inguinal area.  The patient was evaluated in the office and determined to have varicella zoster.  The patient was on the following medications at the time of the event: thyroid (ARMOUR THYROID TABLETS), exetimibe (ZETIA) and HCTZ/triamterene (MAXIDE).  The patient denied any drug reactions, allergies and stated "she does not have a problem with her immune system".  No lab diagnostic studies were performed.  There was no product quality complaint.  At the time of reporting it was not noted if the patient had recovered, but it was reported that "the patient was no longer being treated for this experience".  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information is not expected.
site soreness and residual headache at base of skull x3 days On 12/18 at 12 noon, I found myself passed out in my office at work laying over my keyboard. My assistant had me on-hold at that time and estimated I was out for 1 minute. Was loopy the entire next day. Just hydrated and rested. Felt great by Monday
Phantosmia- I have been smelling cigarette like smells when they aren?t present without having had a Covid infection.
Case number PHEH2016US027889, is an initial spontaneous report received from a pharmacist on 24 Oct 2016. This report refers to a 13-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (lot number: 168805) intramuscular on 23 Oct 2016. The patient was administered partial dose of vaccine. No adverse event was reported following this maladministration (underdose).
flushed face, swelling in face, wheezing, body aches, chills, headache, and fatigue
Itchy and tender to touch rash on one side of my upper left arm next to the injection site. ("COVID Arm")
Site of injection - raised bump. Little redness. Referred to MD told to use cold compress and take BENADRYL.
Pt recv vax on 2/2/99; on same day pt exp fever (104), red/ hot/rash left thigh, vomiting 6-7x;dx=allergic rx to vax; tx=IV, Benadryl, Tylenol, Motrin, cool bath
COMPLAINED of headache and vomiting in pm after immunization of Tdap , Mcv4 and Vz. Fever in AM after 07/27/10. Tylenol was given. Mom was advised to take child to the hospital.