chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain from the shoulder to the fingertips; My whole shoulder; it's been bothering; pain in my arm I woke up with; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 28Apr2021 09:30 (Batch/Lot number was not reported) (at the age of -64-year-old) as single dose for covid-19 immunisation. Medical history included, that patient have carpal tunnel pain from an unknown date and was unrelated to getting the vaccine. The patient's concomitant medications were not reported. Patient called on 29Apr2021 and stated she woke up in the middle of the night took a Aleve, as her whole shoulder was been bothering for a week (pain from the shoulder to the fingertips) from pulling weeds/gardening. Patient felt she overdid it. She took 2 Aleve pm 18 hours after the injection and wanted to know if this would ruin the vaccine and whether she need another vaccine. Patient also wanted to know if there is an efficacy detriment. The patient received the 2nd dose of the pfizer covid vaccine yesterday at 9:30am and queried if that taking 2 Aleve tablets effect the vaccine. She also added that she might have taken some Motrin the day before (18 hours prior to getting the vaccine) but was not sure on that. Patient will just get an antibody test after 2 weeks. Patient also confirmed that the vaccine did not bother her at all. She tried to be so careful but because of the pain in my arm she woke up with. The patient was given a response that antibody testing is not recommended to assess for immunity to SARS CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. In addition, antibody tests currently authorized under an Emergency Use Authorization (EUA) are not authorized for the assessment of immune response in vaccinated people. The patient took treatment with Aleve (naproxen) as a result of the events. The outcome of the events were reported as unknown.   No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
Severe facial swelling Parent reports flattened facial features swelling of the both temporal lobes, swelling of the tongues white spots of stomach and swelling of stomach with stretch mark that remains from swelling. Parent reports infant has had trouble swallowing and staring off in distance since immunization.
A nurse reported the occurrence of an injection site reaction in a 12-month-old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). There was no relevant medical history, concurrent conditions or concurrent medications. The pt had no adverse experiences following receipt of prior immunizations. On 06/18/2002, the pt received his third injection of Infanrix (lot DTPA552A2). On that date, he also received injections of measles, mumps and rubella virus vaccine (MMR II, Merck); inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur); combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax, Merck); and varicella virus vaccine (Varivax, Merck). On 06/20/2002 the pt was seen by the physician and he was observed to have developed an injection site reaction characterized by swelling, redness, and warmth at the site of Infanrix administration. The physician prescribed diphenhydramine and the injection site reaction improved. The reporter considered the injection site reaction to be possibly related to Infanrix administration. Comments: The reporter indicated that this was a second subject experienced an unspecified adverse experience following receipt of Infanrix lot DTPA552A2. However, the subject is not presently identifiable.
Pt reported to the ER with c/o throat swelling, hoarseness, difficulty swallowing and rash RUA.
This spontaneous report as received from nurse refers to an unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated with RECOMBIVAX HB (dose, route and lot number was unspecified) which was improperly stored. No adverse effects were reported. This case is linked to (MARRS# 1411USA11250, 1411USA013447) with the same reporter link. No further information provided. Additional information is not expected.
Have developed painful joint pain/inflammation, knees and hip; Have developed painful joint pain/inflammation, knees and hip; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Feb2021 (Lot number: unknown) at the age of 68 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Drug allergy", notes: Known allergy : Cipro.  The following information was reported: ARTHRALGIA (non-serious), ARTHRITIS (non-serious) all with onset 03Feb2021 at 12:30, outcome "not recovered", and all described as "Have developed painful joint pain/inflammation, knees and hip". The event "Have developed painful joint pain/inflammation, knees and hip" was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia and arthritis.  Additional Information: 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures included physical therapy and unspecified medicine for pain/inflammation. The patient also received Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Anatomical site: unspecified), administration date: 22Feb2021, when the patient was 68 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: UNKNOWN; Anatomical site: Unspecified; Administration time: 14:00), administration date: 18Oct2021, when the patient was 68 years old, for COVID-19 immunisation.   The lot number for BNT162b2 was not provided and will be requested during follow up.
After the 1st vaccine, he began to complain of fatigue, after the 2nd vaccine he became ill quickly. He was hospitalized 8/23/2013 - 8/25/2013 at hospital. He has strep a few times Mono. He has major weakness in joints and muscles. He is not getting better with joint and fatigue and weakness!. So worried.
This spontaneous report as received from a consumer refers to her 32-year-old non-pregnant female patient. The patient's medical history included twin pregnancy. On an unknown date, the patient's twin sons were vaccinated with varicella virus vaccine live (manufacturer unknown) (reported as an unspecified chicken pox vaccine) (lot #, dose, route and site of administration were not reported). On an unknown date, the patient developed shingles after nursing her twin boys. She did not seek medical attention. The outcome of shingles and secondary transmission was reported as recovered/resolved on an unspecified date. The relatedness between the events and varicella virus vaccine live (manufacturer unknown) was not reported. This is one of several reports from the same reporter. Additional information has been requested.
itch in the upper arm; rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itch in the upper arm"; RASH (non-serious), outcome "unknown", described as "rash".  Additional information: Verbatim and Event Description: Caller # heard on the radio that Pfizer is putting a list for the Covid therapeutics, she had bought Ivermectin in a feed store. Her friend had a booster shot and had an itch in the upper arm, also she had a rash 2 and a half weeks later after her booster shot, and wondered if anyone else had it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon reviewing patient's need for 2nd dose, we learned that patient died on 4/25/21.
Swelling under left armpit; Short Fever; Achy Bones; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy Bones), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling under left armpit) and PYREXIA (Short Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Antiplatelet therapy, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced BONE PAIN (Achy Bones), HEADACHE (Headache) and PYREXIA (Short Fever). On 26-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling under left armpit). At the time of the report, BONE PAIN (Achy Bones), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling under left armpit) and PYREXIA (Short Fever) outcome was unknown.      Treatment medication included Tylenol, Nyquil, Advil.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Shot administered 10-11-15. Pt came into store on 1/21/16 stating arm turned red and the shot caused his mind to race. Could not remember how long symptoms persisted - sought no medical attention.
Fever and sore arm, 24-96 hours, post vax. Still has small firm swelling at injection site.
mom reported on 16APR98 pt broke out into hives all over & by 2AM 17APR98 chest felt heavy so walked to amb;amb took pt to ER;
Shingles on eye, progressed to inside mouth (after clinic visit). Prescribed anti-viral Valtrex tablet. Also short of breath, but all other vitals were normal
Itchiness at the injection site started on Feb. 15.  On the morning of Feb. 16, I woke up with redness and swelling about the size of three quarters at the injection site.  My upper arm was swollen and enlarged in size.  I have also been having intense nightmares since February 4.
pt recvd vax & following vax pt had soreness & redness @ the inject site;
Swelling, redness, inflammation (warmth) (severe) at injection site more so than a normal site reaction.
arm started itching; red mark; A spontaneous report was received from a  Consumer concerning a 71 Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm started itching(Pruritus), red mark(Erythema).  The patient's medical history was not provided. Atorvastatin 10 mg, Levothyroxine 50 mcg, Eye drop for glaucoma concomitant medications were reported.  On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 013M20A) intramuscularly in the arm  for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experience the starting of arm  itching and  the red mark appearance.  The patient was treated with Benadryl pill and Benadryl cream for arm itching and for red mark.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was not resolved.
I had the shots, I keep getting shingles/Suspected vaccination failure; I keep getting shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the shots and they did not work. The patient got it repeatedly. Asked was there any suggestions as patient keep getting shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Constant shooting pain in shoulder area, weakness, trouble sleeping, cannot lay on that side, heating pad, Motrin or Tylenol.
The day after the vax, redness and swelling were noted by parents - PT couldn't bear wt. s? area - where she came into the office 2 days after shot, the area was 4" x 3.25" - solu Medrol? 20 mg was given the next day the swelling was down - improvement noted.
Rough whole body achy, migraine, nausea. Lasted for 14-16 hours.
The patient called the next day and said her arm had a large red swollen spot and it was hot to the touch. I told her to take benadryl and to put ice on her arm. She came in the next day (10/23/2019) and showed me her arm and said she had used ice and benadryl and it got worse the second day. The red spot was in the same area of the injection and was also moving down her arm. I told her to take ibuprofen for the inflammation, continue benadryl and ice and to probably not get the second shot of the series.
Patient experienced skin redness and itching during the 15 minute post Pfizer COVID-19 vaccine injection observation period. Patient was given 25 mg diphenhydramine po, and the symptoms were resolved at 1100.  Vitals time       1005          1055         B/P            134/78         130/84     P                65               73     RR             20               16    O2 Sat       98%            99%
Seizures, had to see a neurologist, no action taken. Stopped vaccinating and stopped having seizures about a month later and has never had another seizure since.
On November 14, 2022, my symptoms began as a severe runny nose that turned into nasal congestion.  I ran a low-grade fever.  I took Mucinex and Tylenol.  My symptoms lasted for almost 3 weeks.  I tested negative for COVID-19.
Woke up with Nausea, chills, headache and body aches about 10 hours post second dose of vaccine. Nausea and headache resolved within a few hours. Chills and Body aches lasted about 24 hours post onset of symptoms. I was back to feeling 100% by about 36 hours post vaccine injection.
Per Infectious disease consult note 12/13/21: "Patient is a 59 y.o. male, PMH DM, HTN, seen today for COVID 19 pneumonia.  He presented to the ED with complaints of shortness of breath.  He had been working in his garage Saturday, slipped and fell onto his back.  He had rib soreness and pain with inspiration.  Yesterday, he developed worsening shortness of breath, with sinus drainage, prompting his presentation to the ED.  Recent COVID exposure from a coworker.  He has been afebrile. Admitting labs with PCT 0.2, CRP 1.68, WBC 8.85, Scr 1.26.  CXR with large left pneumothorax measuring at least 30%. CT was placed in ED.  CTA of chest after CT placement, with a very small residual pneumothorax, atelectatic changes in both lungs. Interstitial changes in LUL.  COVID positive.  Started on Remdesivir and Dexamethasone, and we were consulted for evaluation and treatment.   He states that he had Covid 19 infection approximately 1 year ago. He has received both COVID vaccinations, but not his booster. "
Within minutes, I felt my heart racing followed by a pressure on my chest.  I felt like I ran a race and needed my inhaler.   I didn't notify the vaccine administrator, as I thought maybe it was anxiety related.  The symptoms lasted for 4 days.  On the 4th day, I almost went to urgent care as I felt as though I was breathing through a straw.   On the 5th day I woke up and was fine.  It didn't impact my ability to work, but was overall concerning.    I did reach out to my dr's office for advice.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced tachycardia. Additional information has been requested.
Information has been received from a consumer concerning her 8 year old son who was vaccinated with a dose of MMR II. It was reported that the patient developed a fever of 105 degrees after receiving the MMR II. It is unknown if the patient sought medical attention. The patient's outcome was not reported. No further information is available.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4:Moderna /Dose Number: 3: Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 45 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 as dose 4 (booster), single (Lot number: AS7147B), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Temporal lobe epilepsy" (unspecified if ongoing), notes: Other medical history: Temporal lobe epilepsy,; "prediabetes" (unspecified if ongoing), notes: Other medical history: prediabetes. Concomitant medication(s) included: LEVETIRACETAM; ASHLYNA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 4:Moderna /Dose Number: 3: Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of Covid symptoms and positive home test approx 6 days after completing the 5-day course of Paxlovid; Negative, notes: Had an intervening negative home test 1 day after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Levetiracetam ER, combined oral contraceptive pills and Ashlyna in 2weeks. Patient received Paxlovid for Treatment of COVID-19.   No follow-up attempts are possible. No further information is expected.
Tinnitus. Started mild, but now 8 months later it is severe ringing in the ears like a siren.
Greater than six months since first dose / 2nd one yesterday; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 14th January 2020).   On 26th April 2022, the patient received the 2nd dose of Shingrix. On 26th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-APR-2022 and 27-APR-2022 Reporter's Comment: The reporter stated that, he had a patient that it had been greater than six months since the first dose of Shingrix and indicated that, he administered the second dose to the patient. The patient informed that, two year between two shots and second one 26th April 2022. The patient told something about not taking Tylenol or Ibuprofen as it might decrease effectiveness even further. The patient said that, she was already below the normal coverage due to the delay and she didn't want to decrease it further.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR070641:Same patient. Case created in error.
feeling like going to pass out; difficulty breathing; chest pain; Moderate headache; fatigue; moderate muscle aches; joint pain; This is a spontaneous report from a contactable consumer.   A 15-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 06Jun2021 at 11:15 (at the age of 15-years-old) as dose 2 single for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), mood disorder, asthma, NKA other than seasonal outdoor allergies and minor lactose intolerance from an unknown date. Concomitant medications included methylphenidate hydrochloride (CONCERTA); oxcarbazepine (TRILEPTAL) and salbutamol sulfate (PROAIR HFA) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0185 and Expiration date: unknown), via an unknown route of administration, in left arm on 16May2021 at 11:00 (at the age of 15-years-old) for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. On 06Jun2021 at 12:00, the patient experienced moderate headache, fatigue, moderate muscle aches, joint pain, chest pain, difficulty breathing and feeling like going to pass out. Lasted for exactly 48 hours. The case was assesses as non-serious. Patient received Ibuprofen and steroid inhaler as treatment for events. On an unspecified date in Jun2021, the events were recovered.  Follow-up attempts are needed. Further information is expected.
cold urticaria touching cold object (eg. fridge temp Coke Can, holding onto room temperature metal door fram >2 min) results in itching, erythema, hives
woke 8am on 3/17 with dull headache .  12 noon headache became worse.  Took Acetaminophen 500 mg  1pm broke out in cold sweat and became nauseated.  1:30 began vomiting. Remained nauseated, cold sweats off and on, multiple episodes of vomiting until 5pm