chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had shingles after I had the vaccine/ suspected vaccination failure; shingles; nerve pain; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), shingles, nerve pain and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient had shingles after vaccination. The patient had nerve pain in the area of the shingles at the time of reporting. The reporter stated they were painful and took several weeks to heal. The patient had the vaccination when it was first was available and he was told that the new one was better. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
The site started itching 1 week following vaccination with a 2" raised welt at the site with severe itching.  Took Benadryl 25 mg q12 for 1 week thereafter and approved by PCP via patient portal.   Itching subsided. Also advised to have Shot #2 in opposite arm, to  restart the Benadryl prior to arrival for vaccine and to remain under observation for 30 minutes following shot #2.
hurting a little on his chest; Rash over his Chest and back; A spontaneous report was received from a consumer concerning a 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash over his chest and back, hurting a little on his chest.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) rash over his chest and back, hurting a little on chest.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 14 Feb 2021 the outcome of event(s), rash over his chest and back, hurting a little on his chest was resolved.
Patient was in PE in the morning when someone sprayed perfume, and her family is skin sensitive to perfumes. She began to itch and reported it to the front office. They gave her BENADRYL. When she got home her mother told her to shower and gave her more BENADRYL. The next day her rash was worse, head to toe. She was taken to the ER, where she was not given anything, but was told to keep giving her BENADRYL until the rash went away.
5 days following the 2nd shot I experienced a sudden outbreak of hives on my torso, armpits and groin. The hives settled but returned suddenly the following day, but less severe. A small outbreak occurred late in the 3rd day.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 12Apr2021 at 17:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6206) via an unspecified route of administration in the left arm on 17Mar2021 at 17:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 18:30, five days following the second shot, the patient experienced a sudden outbreak of hives on his torso, armpits and groin. The hives settled but returned suddenly the following day, but less severe. A small outbreak occurred late in the third day. None had occurred since. Therapeutic measures were taken as a result of a sudden outbreak of hives on his torso, armpits and groin and included treatment with Bendryl pills. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event five days following the second shot experienced a sudden outbreak of hives on torso, armpits and groin; the hives settled but returned suddenly the following day, but less severe; a small outbreak occurred late in the third day was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Splitting headache and achy body for two days.  Over the counter painkillers did little to ease the pain, like a hatchet chopping my head repeatedly.    Still lingering soreness in left arm at injection site.
This spontaneous report as received from a nurse refers to a female patient of age 25 years. The patient had no drug reactions or allergies. The patient was vaccinated with dose 1, 0.5 ml GARDASIL given intramuscularly (the lot number and expiry date not reported) on 02-MAR-2012. The second dose (dose, route and frequency, lot number and expiry date was not reported) was given on 03-MAY-2012 and the third dose (route dose and frequency not reported) (lot number reported as #0022AE and expiry date reported as 28-SEP-2014) was given on 11-SEP-2012. No other co-suspects were reported. The concomitant medications included an unspecified birth control pill. On 11-SEP-2012 the patient experienced swollen throat, nausea and dizziness after receiving the third dose of vaccine. The patient took BENADRYL and the events resolved within an hour on 11-SEP-2012. The patient sought medical attention and called the physician's office. The relatedness for swollen throat, nausea and dizziness is unknown for GARDASIL. Additional information has been requested.
Patient developed abdominal pain the day after his first HPV vaccine.  Seen at hospital and his ultrasound revealed appendicitis. Patient had appendectomy that day.
Dark blue purple spot on the right hand about the size; Pain in the left Shoulder blade; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size) and ARTHRALGIA (Pain in the left Shoulder blade) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Soreness) and ARTHRALGIA (Pain in the left Shoulder blade). On 16-Mar-2021, the patient experienced SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size). At the time of the report, PAIN (Soreness), SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size) and ARTHRALGIA (Pain in the left Shoulder blade) outcome was unknown.            No treatment information was provided.
9MAY96 mom states pt started crying 2hr p/vax;7MAY96 11AM cried constantly @ times high pitched;mom stated pt has slept only 3hrs in last 48hr period;did not respond to comfort measures;t103 down w/APAP;to ER;ear infect
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 006M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, CLOPIDOGREL, LISINOPRIL, ATORVASTATIN, TAMSULOSIN, AMLODIPINE, VITAMIN C [ASCORBIC ACID] and IRON for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Concomitant medications included centrum. Treatment information was not provided.
patient developed dizziness and syncope in chair in waiting room.  Proceeded to rest on floor to relax and started to have what could best be described as a seizure, having uncontrolled body movements. EMS was called, unknown at this point if patient was released to home or taken to ER
PT received 1st dose of Pfizer and within 5 minutes felt warm/sweaty, fingertips tingling, then experienced near syncope with injury. PT was assisted to the floor for rapid recovery. He was then taken to MED OBS 1. PT reported eating and drinking little today despite working outside. No history of similar evets. PT recovered with the intervention.
Sore arm that went numb for about an hour.  Nausea the day after vaccine Headache for an hour day after vaccine
diff w/mobility of lt arm p/inj;for 2 wk pt has fibromyalgia needed to use muscle relaxor & it did help movement of arm;pt consulted w/pvt MD;
swell and pain in injection arm, after 24 hour pain in the lymph nodes underarm, left side; swell and pain in injection arm, after 24 hour pain in the lymph nodes underarm, left side; swell and pain in injection arm, after 24 hour pain in the lymph nodes underarm, left side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 (Batch/Lot number: unknown) at the age of 66  as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "sarcoidosis in remission," (unspecified if ongoing); "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, administration date 18Dec2021. Vaccination history included: Moderna (prev dose product=COVID 19,, prev dose brand=moderna,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the, time of report completion,, prev dose administration date=Mar2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: Mar2021, when the patient was 65 years old, for Covid-19 immunization; Moderna (prev dose product=COVID 19,, prev dose brand=moderna,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the, time of report completion,, prev dose administration date=Mar2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: Mar2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: LYMPH NODE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "swell and pain in injection arm, after 24 hour pain in the lymph nodes underarm, left side". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymph node pain, pain in extremity, peripheral swelling.  Additional information: patient does not had any known allergies. Patient did hot had COVID prior vaccination. The COVID was tested post vaccination reported as YES. Treatment received for the events included ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; arm was hurting more than sore/arm pain at injection site; Nausea; Loose stools; Left eye twitching; feeling pretty ill/ under the weather; a little short of breath/shortness of breath; Metal taste in her mouth; Itchy everywhere; asthma has flared up a little bit; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH3246, expiry date unknown), intramuscular (right arm), on 08Jan2021, at single dose, for covid-19 immunization. Medical history included asthma since 2004 (diagnosed about 17 years ago). Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) (has been on this for about 2 months) for asthma. The patient previously took formoterol and budesonide (SYMBICORT) for asthma. The patient stated she was a technician and she has a couple of questions about the Covid vaccine. She got the vaccine on 08Jan2021. Since she got the vaccine, papers said she would feel under the weather for a few days but she was still feeling pretty ill; she wanted to know if this was normal and when should she be concerned, wondering if she should call her doctor. She was encouraged to reach out to her HCP for any medical advice. She also stated that 5-10 min after the vaccine on 08Jan2021, she started to feel a little short of breath/shortness of breath but that resolved. Also, afterwards on 08Jan2021 she had a metal taste in her mouth and was itchy everywhere on that day. She went home and around 9PM on the day of the vaccination, she started to feel under the weather on 08Jan2021. Then she woke up on Saturday 09Jan2021 with headaches, chills, joint pain, sore throat, muscle pain/muscle ache, arm was hurting more than sore/arm pain at injection site, nausea, loose stools, and left eye twitching. On Sunday 10Jan2021, she was very tired and slept most of the day. She added that she has been reporting this to the link that was provided to her. She has been taking Tylenol and ibuprofen to treat these symptoms and; was also using her inhaler because it seemed like asthma has flared up a little bit on Jan2021. No other vaccines administered on the same date with the Pfizer vaccine. The adverse events did not require a visit to the emergency room or physician office. No prior vaccinations within four weeks. The outcome of the events feeling pretty ill/ under the weather, slept most of the day and, asthma has flared up a little bit was unknown. The outcome of events a little short of breath/shortness of breath, metal taste in her mouth, and itchy everywhere was recovered on 08Jan2021. The outcome of joint pain was recovering. The outcome of arm was hurting more than sore/arm pain at injection site was recovered on 13Jan2021. The outcome of the other remaining events was not recovered.
achey in legs and head/sore arm; body aches and still has them; real fatigued for a couple days; rash size of quarter on her buttcheek; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (achey in legs and head), RASH (rash size of quarter on her buttcheek), VACCINATION SITE PAIN (sore arm), MYALGIA (body aches and still has them) and FATIGUE (real fatigued for a couple days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced RASH (rash size of quarter on her buttcheek) and VACCINATION SITE PAIN (sore arm). On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (achey in legs and head), MYALGIA (body aches and still has them) and FATIGUE (real fatigued for a couple days). On 22-Mar-2021, RASH (rash size of quarter on her buttcheek) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, PAIN IN EXTREMITY (achey in legs and head), MYALGIA (body aches and still has them) and FATIGUE (real fatigued for a couple days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. Treatment history includes Advil and Tylenol.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter address, Vaccine lot numbers and dates, pt height/weight, race, PMH, product history, event narrative and outcome.
1/28/2021  received her 1st dose of Pfizer COVID-19 vaccine yesterday and about an hour later started experiencing numbness of her nose, mouth and tongue, she also felt eye pressure and thought she was going to have a migraine but never got a migraine. Now (about 19 hours later) the numbness is about 75% resolved. not too concerned about it and would like to receive her 2nd dose of vaccine. So far she has not had any other notable adverse reaction. will call me next week to follow up. 2/3/2021--called and reports that  still experiencing numbness of her nose, mouth and tongue but it has resolved a little
Constant itchiness all over my body after 2nd dose of Moderna Covid-19 vaccine. Doctor prescribed steroids and steroid shot. Temporary relief from steroid shot. No change with steroid pill. 1st dose on 4/2/2021- itchiness only on palm and toes. Started 8 days after receiving vaccine. Bumps and pointy spots on palm and toes. Doctor prescribed steroid pills 20mg for 5 days.
Incorrect vaccine administered, should have received Bivalent adult dose (dark blue cap, 0.25ml), no adverse effect reported. Patient has since received correct vaccine at another pharmacy.
Covid-19; Covid-19; This is a solicited report from a study based on information received by Pfizer from a company, manufacturer control number: 21K-163-4046327-00. A contactable 81-year-old female consumer (patient) reported that she received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) via intramuscular route of administration, dose 1 in Jan2021 (Batch/Lot number was not reported), dose 2 on 10Feb2021 (Batch/Lot number was not reported) both as single dose at the age of 81-year-old for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at CF for moderate to severe adult crohn's disease. Medical history included moderate to severe adult crohn's disease. There were no concomitant medications. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced covid-19 on unspecified date in 2021 with outcome of not recovered. The action taken in response to the event for adalimumab was unknown. Relevant laboratory & other diagnostic test included COVID-19 test: positive on unknown date in 2021.                                   Causality for Covid-19 with adalimumab as per reporter (Drug/Vaccine) was no reasonable possibility; with PFIZER BIONTECH COVID-19 as per reporter (Drug/Vaccine) was possible.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective, COVID-19 cannot be completely excluded.
burning pain in my hands inside of arms where they bend at the elbow and behind my knees; burning pain in my hands inside of arms where they bend at the elbow and behind my knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE. Vaccination history included: Bnt162b2 (Dose number 1), for COVID-19 Immunization; Bnt162b2 (Dose number 2), for COVID-19 Immunization; Bnt162b2 (Dose number 3), for COVID-19 Immunization; Bnt162b2 (Dose number 4), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "burning pain in my hands inside of arms where they bend at the elbow and behind my knees". The events "burning pain in my hands inside of arms where they bend at the elbow and behind my knees" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, arthralgia. Additional information: It was a report about covid vaccine. There is no other vaccine in four weeks. Other medications in two weeks: Cyclobenzaprine. Since receiving 5 of the Pfizer vaccines, patient have been having burning pain in the hands inside of arms where they bend at the elbow and behind the knees. They feel like debilitating pains and has made it difficult to do daily task and job at work. The patient had gone to the PCP and had blood labs done, but can't figure out why this has happened. AE resulted in Doctor or other healthcare professional office/clinic visit. No known allergies. No covid prior vaccination. There was covid tested post vaccination: Nasal Swab on 18Oct2021: Positive.
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 10-MAY-2018, the patient was vaccinated with an improperly stored PEDVAXHIB lot # R000876 with an expiration date 26-SEP-2020 for prophylaxis (dose, route of administration and anatomical location were not reported). Administered dose of PEDVAXHIB was in the shipping container and it was unknown what temperature the vaccine reached and for how long. There was no adverse effect reported. There was no previous temperature excursion. A digital data logger was not involved.