chrisvoncsefalvay/vaers-outcomes huggingface dataset:
each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Second dose, Lot. EN6206), administration date: 19Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Third dose, Lot. FH8027), administration date: 14Nov2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Fourth dose, Lot. FK9894), administration date: 19Apr2022, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Pain in lower back/right glute; Pain in lower back/right glute; DOSE 1; 09Aug2021; Dose 2: 23Aug2021; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Aug2021 at 15:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included bulging and degenerative disc and the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Aug2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 23Aug2021 at 20:00, the patient experienced pain in lower back/right glute. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in lower back/right glute was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After temperature excursion of 82.3 degrees F, vaccine is nonviable.  Patient received nonviable vaccine
BLOOD CLOTS; SORE THROAT; This spontaneous report received from a parent concerned a 40 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a sore throat and blood clots after receiving the Janssen coronavirus disease-19 (COVID-19) vaccine (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and sore throat was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220126392-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
pt recvd vax;mom states had few whelps on back;gave apap;3:45pm has whelps on arms,legs,back,face,stomach;no fever;mom instructed to take pt to er or PMD;to MD,was told whelps were not related to immun;poss unk allergy;gave dph,whelps gone;
2 weeks after receiving varicella developed (1) blister area on chin and (1) at injection site also fine rash on chest and back.  No fever.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M011832, expiration date 25-JAN-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit (34.4F) for 15 minutes. A digital data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA012988: US-009507513-1711USA007835: US-009507513-1711USA007836:
Myalgia followed by rash on face- papular, and diarrhea.  On 1/6/10 rash more pronounced, fatique.  On 1/7/10 at 1:00AM developed tightness in chest and trouble breathing.  No wheezing or fever, no angiodema.  Seen in hospital emergency room at 2:30 AM
Arthritis flare ups; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flare ups) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis flare ups). At the time of the report, ARTHRITIS (Arthritis flare ups) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported. Treatment information was not provided.
Swelling on arm, spreading redness, fever in area. Took benedryl, I would wake 6 times during the night with my arm asleep, I was not sleeping on it, I was on my back.
I just started coughing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (I just started coughing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 COUGH (I just started coughing). At the time of the report, COUGH (I just started coughing) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Flu shot on 11OCT & on 12OCT exp h/a, malaise followed by severe abdo pain, brief fever, loose stools, nausea; In bed for 2 days following shot; Seen by MD on 15OCT-exam & lab WNL; rx Cotrin-DS;
Swollen lymph node in L armpit; General malaise; Myalgia; This is a spontaneous report from a contactable pharmacist. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the arm left on 16Apr2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the arm left on 26Mar2021 at 15:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Apr2021 at 10:00, the patient experienced swollen lymph node in left armpit, general malaise and myalgia, noted upon waking the morning. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the events swollen lymph node in left armpit, general malaise and myalgia was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Received IM injection in left shoulder. Developed diffuse edema in my armpit two days later without palpable lymphadenopathy. Worsening over the last 48 hours.
Starting about 12 hours after the injection, I awoke with a fever of 101, body aches, and severe headaches.  The symptoms progressed and my fever was over 102 most of the day and hit a max of 103.5 around 2:30pm.  Nausea started around 4pm, which I alleviated by taking Zofran.  I eventually went to bed and awoke on the second day around 4:30am with a fever at 101 still.  Then around 7:30am, the fever broke with the most intense full body sweats.    Later on that Friday, in the afternoon, I noticed a large red rash on my right arm at the injection side, it was slightly swollen and very hot.  It got bigger over the next 12 hours or so and by Sunday afternoon the swelling had subsided and now appears and feels like a sunburn where the redness turns white if you press with a finger and then returns to red and it also itches now.  I treated the itchiness with some hydrocoritizone cream.
Patient complained of lightheadedness and malaise on the evening of 06/03/2014. On the morning of 06/04/14 he woke with redness at the site of injection. Per mom, patient was evaluated by his PCP and told to monitor site. On the evening of 06/04/2014 he developed fever, chills, and sweating. On the morning of 06/05/14 he went to the ER. His WBC was 25,000 (per mom). He was given IV antibiotics and was sent home on oral antibiotics. Symptoms worsened and he returned to ER on the evening of 06/05/2014. He was admitted to the hospital and is currently still there receiving IV antibiotics. Per mom, when the antibotics were stopped today the redness and swelling of his left arm increased.
Swollen lymph nodes, soft, tender, bean sized along collar bone. All on the left side only; This is a spontaneous report from a contactable consumer (patient). A 33 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, 33-year-old at vaccination), via an unspecified route, administered in Left Arm on 15Apr2021 at 11:00 (Lot Number: ER8729) as a Dose 1, Single and via an unspecified route, administered in Left Arm on 06May2021 at 11:00 (Lot Number: EW0168) as a Dose 2, Single, both doses for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included IBS (irritable bowel syndrome). No known allergies. There were no concomitant medications within two weeks of vaccination. Facility type vaccine was reported Pharmacy or Drug Store. The patient was not tested for Covid prior vaccination. The patient had not received any other vaccine within four weeks prior vaccination. On 07May2021, the patient had experienced swollen lymph nodes in armpit, soft, tender, and about golf ball sized swollen lymph nodes, soft, tender, bean sized along collar bone. All on the left side only. These adverse events did not resulted in emergency room/physician office visit. No treatment was received for resulted events. The patient was not tested for Covid post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Information has been received from a physician concerning a 2 month old male with acid reflux and a history of respiratory syncytial virus RSV (beginning of March 2006) who on 4/4/2006, at a well baby visit, was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653754/0139F). Concomitant vaccinations administered on that same day included standard vaccines given at 2 months of age (physician did not provide actual product name). Other concomitant therapy included lansoprazole Prevacid. At the time of vaccination the patient was noted to be fine. On 4/7/2006 the patients parents phoned the physician indication that their son had been vomiting excessively. He also noted to be pale, listless at times and was sometimes crying as he seemed to be crampy. The physician instructed the parents to take their son to the ER. In the ER the patient was treated with dextrose + electrolytes unspecified Pedialyte and was released. ON 4/8/2006 the patient was seen in the physicians office and was still having episodes of vomiting. On 4/11/2006, the patient was again seen in the physicians office. At that time, his vomiting had improved but his appetite was somewhat decreased. The parents noted seeing small streaks of blood in their sons stool. The patients stool was tested and wag guaiac positive. The physician indicated that the stools were not grossly bloody and the patient was afebrile at that time. On 4/13/2006, the patients formula was changed to Alimentum. After the change in formula, the patients symptoms were noted to have greatly improved. On 5/5/2006 the the patient was vaccinated PO with the second dose of  rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653754/0139F). at the time of dose two, the patient was doing fine and was noted to be gaining weight. The physician was unsure if the patients events were related to a possible protein sensitivity or rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). At the time of this report, the physician was not totally convinced of either. The reporting physician considered excessive vomiting to be other important medical event (OMIC). Additional information has been requested.
Soreness in right arm; chills; muscle soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 10:30 as dose 4 (booster), single (Lot number: GJ6742) at the age of 27 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergy: Penicillin" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, on 26Oct2022 as dose number unknown, single; KURVELO; FLUOXETINE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot no: EL3247; Route of administration: intramuscular; Location of injection: arm right), administration date: 25Jan2021, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "slight soreness in my right arm"; BNT162b2 (DOSE 2, SINGLE; Lot No: EL3247; Route of administration: Intramuscular; Location of injection: Arm right), administration date: 15Feb2021, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "fatigue", "My right arm was also a bit sore", "I had slight muscle soreness", "Very slight chills"; BNT162b2 (DOSE 3, SINGLE; Lot no: EW0217; Route of administration: Intramuscular; Location of injection: arm right), administration date: 14Oct2021, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "Stomach ache", "Injection site slight pain", "Fatigue", "Chills". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Nov2022 at 21:00, outcome "recovering", described as "Soreness in right arm"; CHILLS (non-serious) with onset 10Nov2022 at 21:00, outcome "recovering"; MYALGIA (non-serious) with onset 10Nov2022 at 21:00, outcome "recovering", described as "muscle soreness". Therapeutic measures were not taken as a result of pain in extremity, chills, myalgia.  Additional information: It was reported that, the patient received other vaccine in four weeks. The patient had not been tested for COVID post vaccination. Other medical history was reported as no. Adverse events did not result in Emergency room visit or Physician office visit.
After the 2nd shot, my period came a week early and was unusually heavy. The cramping and clotting is always over by day 3, and this time it was still continuing on day 4. There was enough clotting and blood loss that I was concerned for my health. On day 4, I was seeing 4-6 clots every time I changed my pad.
Patient felt light-headed and dizzy immediately following vaccine. She also started to feel warm and clammy. The symptoms progressed over the next several minutes and were not improving. Store management was called to the pharmacy as a precaution. After about 10 minutes, the patient stated her symptoms were improving. At that time, she agreed to walk to a waiting chair outside the pharmacy and was watched by pharmacy staff for the next 25-30 minutes. She said she felt fully back to normal by the time she left with the person she came with (her mom).
I received the vaccine at 2pm on January 5, 2021. At 8pm I started to feel tightness in my chest.  Then it kept getting worse, and developed a burning feeling when I breathe. It has been intense since then.
Diagnosed with shingles; Red itchy bumps on back; Red itchy bumps on back; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-FEB-2023, the patient received the 1st dose of Shingrix (left arm). In FEB-2023, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: Diagnosed with shingles), itchy rash (Verbatim: Red itchy bumps on back) and papular rash (Verbatim: Red itchy bumps on back). The outcome of the shingles, itchy rash and papular rash were not resolved.   It was unknown if the reporter considered the shingles, itchy rash and papular rash to be related to Shingrix.     It was unknown if the company considered the shingles, itchy rash and papular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2023 The reporter was the patient. The patient reported that she got her first dose of Shingrix vaccine and that about 3 days later she got some red, itchy bumps on the left side of her back.  She went to the physician and it was diagnosed as Shingles.   The bumps were still present.   She did not have any further information about the vaccine. The reporter did not consented to followup.
I had a little bit of a sore arm but not severe. Within a week, I started having numbness in my right fingertips - all the fingers. And it once it started it was so consistent that almost didn't get 2nd COVID vaccine. My left hand was also numb in the finger tips by the time I got the second vaccine. The second vaccine was on April 16th. The left hand resolved itself probably about a month after the second COVID vaccine (in May). Right hand continues to have numbness in the fingertips. I have chiropractic treatment that hasn't helped. I have seen my Primary care physician as well.
Burning of my heart; Burning of my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 15:00 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "plantar fasciitis" (unspecified if ongoing); "Allergies: artificial flavors" (unspecified if ongoing). Concomitant medication(s) included: TYROSINE; GTA FORTE II; SELENIUM. Past drug history included: Xanthan gum, reaction(s): "Allergies: xanthan gum"; Bactrim, reaction(s): "Known allergy:Bactrim"; Z-pak, reaction(s): "Known allergy: Z-pak"; Codeine, reaction(s): "Known allergy: codeine"; Phenergen, reaction(s): "Known allergy: phenergen"; Gelatin, reaction(s): "Known allergy: gelatin"; Msg, reaction(s): "Known allergy: MSG", notes: MSG; Acacia gum, reaction(s): "Known allergy: acacia gum", notes: acacia gum; Carag, reaction(s): "Known allergy: carag", notes: carag. The following information was reported: BURNING SENSATION (non-serious), CHEST PAIN (non-serious) all with onset 20Aug2021, outcome "recovered" (22Aug2021) and all described as "Burning of my heart". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient received other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: Supplements and reported under concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19: No. Since the vaccination, the patient has been tested for COVID-19: Yes. Patient had reported AEs more mildly after the first shot for about 2 days after the shot.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt. tested positive for COVID-19 on Jan. 6, 2022 and succumbed to the illness on Jan. 11,2022.
Fever as high as 105 R- devel day p/ 17MAR 24 hrs later resolved about evening the following day 18MAR afebrile on 19MAR AM; no appointment 18MAR PM;
Rash on face then all over body within hours of vaccination. Itching began 05/11/2010.
Little to no shoulder range of motion, neck pain, shoulder muscle pain, injection site was almost to corner of shoulder (too high)
Fever of 102.5 F. Nausea, chills, headache, muscle ache, stomach ache, and difficulty urinating.
Inc soreness to inject site with redness. No swelling, no chills approx 72 hrs post administration.
Within a month of receiving my Covid booster in 11/21 I starting feeling itchy all over my body.  I could tell my body was starting to react to something and ultimately it would become hives.  I had never experienced anything like this before!  I also had not put anything different or new in my body.  My skin then became overreactive to anything that scraped, touched, brushed or scratched me.  I would get bright red welps & hives anywhere & everywhere all over my body.  It was not isolated to one area. I have been dealing with the hives for 1.5 years now.  I must take OTC allergy medication (Zyrtec, Allegra) 2x daily or my skin is uncontrollably itchy.  I also receive monthly Xolair shots to control the hives from my Allergist.