chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Normal pain following injection, within 24 hours noted increased pain, worse with movement, decreased range of motion- described pain as throbbing, made it difficult to sleep, pain mostly in upper inner arm. Pain is worse with raising arm, or moving across midline, or reaching behind. Had pain in neck ongoing, pain in L shoulder blade and with inspiration beginning 11/8/17. Has had headaches on and off since receiving vaccination. Saw physician approx. 3 weeks later, had a steroid injection and was given steroid dose pack which helped- felt about 85% better. Also had muscle relaxers but these were not as helpful, only took a couple. Has Excedrin since vaccination and this has helped with headache and decreased pain. Does not relieve completely but makes it more manageable. Pain in shoulder had resolved, but noted it returning 11/6/17 when putting on shirt and when reaching for items behind. Has resumed taking Excedrin and feels it is still helping. Notes pain gets worse later in the day. Feels better if sleeps on side where vaccination was administered or on back. Wakes up at night with aching pain.
stressed; it makes his blood pressure go up and that makes him blind in one eye; it makes his blood pressure go up and that makes him blind in one eye; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number and expiration date were not reported) at the age of 70-years-old at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and his daughter (58 years old female) received their first dose of the Pfizer COVID vaccine on 06Apr2021 and second dose is scheduled 4 weeks later. The patient wanted to know how he can take the second dose in 3 weeks and stated that because he was stressed about the appointment time, it makes his blood pressure go up and that makes him blind in one eye. The outcome of the events was unknown.  Information about lot/batch number has been requested.
The left shoulder, where I was given the shot became raised, red and painful after both shots. I did not notice when it started after the first shot, but it lasted about a week. I just received my second shot yesterday & the same thing happened, but this morning I woke up feeling tired, achy & with a body ache & broke out into hives on both legs  & feet, both arms & hands and my neck. The hives went down & stopped itching after I took some benadryl, pepsid, & sprayed w/ hydrocortisone spray, but came back about 4 hours later. I took more benadryl & sprayed w/ hydrocortisone spray, but am still itchy & w/ hives.
This case was reported by a physician and described the occurrence of itching in a 37-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 10 October 2012 at 17:50 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 10 October 2012, at 23:00, approximately 5 hours after vaccination with FLULAVAL, the subject experienced itching. The physician stated that the subject "continues itching all over the past 9 days since receiving a FLULAVAL shot" on 10 October 2012. The subject "waited seven days, and treated /relieved the itching with over-the-counter BENADRYL on 17 October 2012." He then reported the experience to the physician on 18 October 2012. At the time of reporting the event was unresolved. The physician stated that the itching continued to persist at the time of the report. The physician reported concern over the length of time that the itching had persisted and will continue monitoring. The physician considered the event was possibly related to vaccination with FLULAVAL. Follow-up information was received on 14 November 2012 via physician who reported the subject's event of itching started on 10 October 2012 and resolved on 24 October 2012. No other information was provided.
11/27/21:  Complaints of feeling unwell with productive cough and nausea X 2 weeks.  Head ache for last three days.  Had increased SOB and chest pain with deep inspiration so went to PCP who then sent patient to the ER for evaluation.  In ER noted CRP 3.1, d-dimer 274, ferritin 203, LD 522, CXR shows bibasilar atelectasis and/or infiltrates.  Temp 37.3 C, Sat 89% on 3L NC, RR 20's with moist cough.  Auscultate bilateral scattered rales in bases.  Admitted with acute hypoxic respiratory failure secondary to COVID 19 PNA.  Started on IV ceftriaxone, IV doxycyline, IV decadron, remdesivir, and baricitinib. 12/2/21:  Hospitalization uneventful.  Arrangements made for resumption of home oxygen upon discharge.
It has been six (6) days since my first Moderna shot. The first day of the shot, I felt arm soreness, fatigue, and a slight headache about 3 hours after the injection. The next day, I woke up slightly nauseous and a slight headache. Every day, I've noticed a slight headache on and off throughout the day, fatigue, and nausea. Today (3/31), I still feel nauseous. I also feel a bit of tightness in my chest, a slight burning sensation in my back (down my lower spine), a stronger headache, and fatigue. I feel a bit "off."
Dad broke out in chicken pox rash, 4 hours after child got Varicella booster.
Male caller , calling on behalf of his spouse stating she received her 2nd dose of the Moderna Vaccine yesterday,  3/20/2021 and this morning around 1000 she began having chills with a 100.5 temp, she now has a temp 104.5 and caller was instructed to take his spouse to in-person care for further medical management. Caller verbalized understanding and agreed to a 24 hour callback on 3/22/2021 at 1715.  RN 3/21/2021 @ 1725
225PM PC made by mom pts' temp was 98/5 (ear);pt had been exp unconsolable crying since 11AM;mom gave pt APAP @ 1PM for pain;nurse recommended warm tepid bath,cool compress to lateral thigh which is red,edematous & tender to touch;
Severe right shoulder, upper arm pain, could not move arm. Given Vicodin by private provider and sent to ortho, gave Prednisone taper.
The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Global Medical Information (GMI) (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is 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 is 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 has contributed to or is to be held liable for the occurrence of this medication error.
PATIENT EXPERIENCED A NON-ITCHY RASH ON THE NECK, ABOUT 5-INCHES BY 1.5-INCHES
Information has been received from a physician concerning a 7 year old male who was vaccinated at a county health department 6 years ago, in approximately 1998, with a dose of varicella virus vaccine live (lot # 625373/0058H). The patient has been diagnosed by a private physician with breakthrough varicella. The patient has approximately 62 lesions with a low grade fever. Unspecified medical attention was sought. The outcome was reported as recovering. The physician also indicated that the patient was exposed to his cousin with breakthrough varicella (WAES0407USA02520). There was no product quality complaint. The reporter also mentioned 40 cases of breakthrough varicella (WAES0408USA00172). Additional information has been requested.
Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise   My concern is that now post 23 days after 2nd vaccine, I?m still having fatigue, no endurance, mild/moderate body aches, worse at night, still some episodes of loose stools.
Presented with diarrhea, abd pain, fever, weakness; + covid; CXR - scattered groudglass opacities; Tx- Decadron, Lovenox, singulair, zinc; Was on O2 for brief period for comfort, O2 is now 93-95% on RA No remdesivir as illness started 9-10 days PTA; pt with mild acute renal failure, rec'd IV fluids and Cr improved
After the shot on Thursday I felt normal. On Friday I felt slightly less steady getting around, but upon returning home Friday afternoon I felt 4 times before getting to my bed. This falling was accompanied by a severe sense of weakness. One fall resulted with ending in the bathtube from which I needed major health to return to be seated on my walked. Once in bed I did not leave bed for 24 hours. After bed rest I was again mobile. During my weakness I felt like a big slug. My vitals were normal except pulse which was stead but over 100/min. I normally have a 50-60 pulse rate, I had no pain. I had normal body functions, was alert, and slept well. I think I am fully recovered. During this episode I was attended to by my niece, BRN. I was not given any medication.
The patient's mom reported even several days later. She reported a rash on torso and neck with a knot and redness at the injection site.
Phlebitis (superficial) in both lower legs. Redness. Swelling and soreness.
Severe muscle pain all over but worse in neck, back and both arms. Muscle weakness in both arms. It hurts to hold the neck up, having a hard time typing, picking things up, pushing things and grasping things due to weakness and pain. Also having muscle twitching and trembling in index fingers and thumbs and all over the body. At night twitch to the point that I keep waking up and body jerking at times as well. Also, extreme fatigue.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 5 (booster), single (Lot number: 6j6739), in left arm and on 01May2023 at 16:30 as dose 6 (booster), single (Lot number: Gj3260) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: Er2613), in left arm, on 15Apr2021 as dose 2, single (Lot number: Ew0169), in left arm, on 15Dec2021 at 08:30 as dose 3 (booster), single (Lot number: Fj8757), in left arm and on 19Jul2022 at 00:15 as dose 4 (booster), single (Lot number: Pp7139), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "obese" (unspecified if ongoing); "sports injuries" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TREATMENT FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of treatment failure, covid-19 with Paxlovid from 10Sep2023 to 15Sep2023.
she had a reaction to an unknown vaccine in the past / it may have made the patient's unknown skin condition worse; she had a reaction to an unknown vaccine in the past / it may have made the patient's unknown skin condition worse; This spontaneous report as received from a female patient of unknown age who reported on herself. There was no information about the patient's concomitant therapies or medical history provided. Her concurrent conditions included unspecified skin condition.     On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (it was also reported as unknown vaccine, conflicting information).  On an unknown date, the patient had a reaction to the vaccine and it may have made her unknown skin condition worse. The outcome of the events was unknown. It was unknown, if the patient received any treatment for the event or sought any medical attention. It was also reported she was concerned because she wanted the shingles vaccine that is a two part series, because the single dose may not be effective enough and she was concerned that she would develop shingles.  The causality assessment between the events and the suspect vaccine was unknown (since it was reported that she had a reaction to an unknown vaccine in the past and it may have made the patient's unknown skin condition worse, however it was also reported that "she did not state if the shingles vaccine caused an issue" (conflicting information)).
she had a bruise for a month and a half; This is a spontaneous report from a contactable consumer or other non-health care professional reported for her mother-in-law (patient). A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. It was unknown if patient was pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the consumer niece had sent an email to the caller and said that the niece's mother-in-law had her COVID vaccine, and she had a bruise for a month and a half. The niece said that it was not unusual for that to occur if someone was on blood thinners. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021302405 same reporter /drug, , different patient and event
chest warm in the back and front.like sunburn; pain in the arm; fever; A spontaneous report (United States) was received from a physician concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain, skin burning sensation and pyrexia.  The patient's medical history was not provided . No relevant concomitant medications was reported.  On 7-jan-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number : 011j20A) intramuscularly for the prophylaxis of COVID-19 infection.  On the same day, the patient experienced pain in the injection site , chest warm and fever during 48 hrs. Treatment for the events was unknown.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of report, the outcome of the events, pain at injection site, fever and chest warm was unknown; Sender'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. Further information has been requested
Janssen COVID-19 Vaccine EUA At 11 PM the night of the vaccine (Saturday), extremely bad chills, fever and weakness set in almost immediately. I could not get my body to warm up and was borderline too weak to walk. Very bad headache and nausea set in as well.  After several hours the chills turned to intermittent sweating/cold and I could not keep a consistent body temp, nor sleep that night. The next morning  (Sunday) I had very bad aches and soreness, along with chills/fever and headaches that could be managed fine with around the clock acetaminophen. Around 8 PM that night, most of these flu like symptoms subsided. The following morning (Monday), still very exhausted despite a full 10 hours sleep. Tiredness and weakness lasted through the day. Tuesday morning until around 3 PM i still experienced drowsiness and was unable to gain strength for anything more than typical day to day tasks (could not workout). Wednesday morning, felt normal but while exercising experienced shortness of breath almost immediately as well as chest/lung pain easily. Come Thursday I feel 90% normal.
Hives, roof of mouth itchy, throat hurt, eyes red, face red. BENADRYL given.
Dizziness; Nausea; This is a spontaneous report from a non-contactable consumer (patient's sister). A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was calling on behalf of her sister.  She stated her sister got the Covid vaccine yesterday and had had dizziness and nausea all day today. She wanted to know what to do to stop this. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
IM vaccination was  given in LUE deltoid. On the day of the vaccine felt slightly dizzy and more fatigued. The following day, I developed a painful, enlarged lymph node in left supraclavicular area. The next day I felt overall weakness and tiredness. No fever noted, but I was frequently flushed and had hot flashes with perceived sudden weakness. I had slight nasal congestion and prolonged sneezing spells on the following days. I had to find a place to sit down and remove my lab coat and turn down the heat because of hot flashes at work. I had fecal urgency and loose stool x 2 on 3/5/21. I have mild lymph node enlargement in left neck today (2/6/21) that is not painful. I had pain at the injections site for 2-3 days after the first vaccine injection that awakened me from sleep a couple of times. The second injection was given in the same arm. All of my symptoms are easily managed with Tylenol, Motrin, fluids and rest.
Patient was accidentally given Moderna for his second shot in the COVID-19 vaccination series. Patient received first dose of Pfizer on 3/17/2021. Patient was notified. No adverse effects at this time
Patient came for his second dose of COVID-19 vaccine. Before giving the vaccine, I asked the patient if they had any problems with the first dose and they stated that they did not. After giving the vaccine I went back inside the pharmacy to throw away the supplies and his son-in-law called me over to take a look at the patient. The patient had his eyes closed and head tilted back and started shaking for a couple of seconds. I had my technician call 911 at this moment. The patient has lost consciousness and I took the patients mask off to assess and confirm that he was breathing which he was. Upon regaining consciousness the patient was disoriented and sweating. Unfortunately it was difficult to find out how the patient was feeling due to a language barrier. I monitored the patient until the paramedics arrived which they took out the EKG and injected him with an IV. His BP was 107/62, HR in the 70s, and not sure if I overheard correctly but bloodsugar of 163. The EKG report stated that the patient was having a STEMI but when they printed it out there was no ST elevation. The paramedics took care of the situation and took him in for further evaluation.
have bleeding in her mouth.; didn't feel good at all that day , and they fought with the pharmacist.; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH HAEMORRHAGE (have bleeding in her mouth.) and FEELING ABNORMAL (didn't feel good at all that day , and they fought with the pharmacist.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046c21a and 004f21a) for COVID-19 vaccination.   No medical history was provided by the reporter.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced FEELING ABNORMAL (didn't feel good at all that day , and they fought with the pharmacist.). On 18-Oct-2021, the patient experienced MOUTH HAEMORRHAGE (have bleeding in her mouth.). At the time of the report, MOUTH HAEMORRHAGE (have bleeding in her mouth.) and FEELING ABNORMAL (didn't feel good at all that day , and they fought with the pharmacist.) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Zyrtec were reported as concomitant no treatment medications was provided patient need a specialist to draw blood for them. patient felt sick. patient received 2nd dose on 21st sep 2021   This case was linked to MOD-2021-367181 (Patient Link).
Was supposed to start menstrual on or about 4/18. Menstrual arrived, but was extremely light and lasted less than 24hrs. Every month, menstrual did arrive, but was unpredictable onset, light and spotty. All under 24hrs duration and progressively less each time. Last menstruation 9/18/21, almost non-existent. Not enough for hygiene product usage. Couple of spots, lasted approx 12hrs duration.Maybe<1 tsp total discharge. No cramps or abdominal pain experienced. Did not report to Dr yet as I just realized possible correlation with vaccine.
Asymptomatic COVID-19 infection (exposed to COVID+ roommate inpatient)