chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received ACTHIB with expired diluent /no AE; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case from a health care professional.  This case is linked to case 2020SA256170. (same reporter, age, gender and initial reported for two patients).  This case involves a 15-month-old male patient who received a dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACTHIB], with expired diluent (expired product administered).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On 10-Sep-2020, the patient received a fourth dose of 0.5 ml of suspect HAEMOPHILUS TYPE B (HIB) VACCINE [Vaccine Powder: lot UJ125AGA, expiry date: 02-Nov-2020 and for Diluent: U6337AA, 12-Aug-2020] via an intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.   HCP wanted to known harm associated with receiving a 5th dose of ACTHIB, and how soon the dose with non expired product can be given.  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 and parent presented to Covid testing / immunization facility located in drive through. The patient requested Pfizer. Pfizer vials were not immediately available downstairs at the time. The patient was asked all questions on the questionnaire. After waiting at least 15 minutes, patient?s parent requested Moderna since it was readily available & they were waiting. Patient was given the Moderna vaccine instead of the Pfizer.  Mother was contacted after the event was noted & reports no adverse signs or symptoms.
On day 11 (2/2/21) my left arm got itchy, swollen, hot and bumpy.  A few days later,  a PA friend looked it up and said it was something new called COVID Arm.  I've been treating it with neosporin (in case of infection) and ice.  Each day it gets a little better.  Today is 2/9 and there is still a small residual effect.
Extreme rash on back, chest, armpits, arms,  inner thighs and progressing some each day.
Pt recvd 1st dose of Recomb on 9JAN91 w/no adverse rxn; 2nd dose recvd 7FEB91 & 6 hrs later exp generalized coldness numbness in fingers & toes, shaking & shivering; sx persisted for approx 10 min a/remitting;
Eyes rolling! Hand flapping! Screaming for hours! Redness!  Rocking back and forth! Touching head continuously. Vaccine injury!!!!!!!!!!!!!!!!!!!
Seizure, grand mal, lasted 10 seconds, postictal up to 10 minutes
Red blotch at site of injection; Itchy at site of injection; Raised area (bigger than a half-dollar) at site of injection; Burning sensation at site of injection; Raised area (bigger than a half-dollar) at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotch at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE SWELLING (Raised area (bigger than a half-dollar) at site of injection), VACCINATION SITE PAIN (Burning sensation at site of injection) and VACCINATION SITE RASH (Raised area (bigger than a half-dollar) at site of injection) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Poison ivy rash.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH MACULAR (Red blotch at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE SWELLING (Raised area (bigger than a half-dollar) at site of injection), VACCINATION SITE PAIN (Burning sensation at site of injection) and VACCINATION SITE RASH (Raised area (bigger than a half-dollar) at site of injection). The patient was treated with HYDROCORTISONE for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red blotch at site of injection), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE SWELLING (Raised area (bigger than a half-dollar) at site of injection), VACCINATION SITE PAIN (Burning sensation at site of injection) and VACCINATION SITE RASH (Raised area (bigger than a half-dollar) at site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On 09-Mar-2021, the patient developed a red blotch, raised (bigger than half-dollar) area, burning sensation, itchy. On 11-Mar-2021, symptoms disappeared. On 16-Mar-2021, developed another red blotch (more red than previous reaction), raised area, itchy, all at site of injection. Treatment with hydrocortisone cream was given and some symptoms resolved. On 17-Mar-2021 symptoms still persist.   This case was linked to MOD-2021-109664 (Patient Link).
Information has been received for the Merck Pregnancy Registry for GARDASIL from a health professional concerning a 20 year old white female with no pertinent medical history, drug reactions/allergies.  On 24-OCT-2007 the patient was vaccinated with a first dose of GARDASIL (lot# 658488/1264U) 0.5 mL IM.  There was no concomitant therapy used.  On 24-OCT-2007 the patient tested positive on a home pregnancy test after receiving the first and only dose of GARDASIL.  Medical attention was sought.  The patient called the office.  No further information was available.  The date of the last menstrual period was 26-SEP-2007 and the estimated date of delivery is 02-JUL-2008.  Follow up information was received which reported that in February 2008 the patient had an elective termination at approximately 19 weeks of pregnancy.  Additional information is not expected.
Caller added he was diagnosed with COVID-19 infection last week.; Caller added he was diagnosed with COVID-19 infection last week.; sick; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional) from medical information team. The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FF8839) at the age of 40 years as DOSE 1, SINGLE for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant) with onset 21Dec2021, outcome "not recovered", SUSPECTED COVID-19 (hospitalization, medically significant) with onset 21Dec2021, outcome "not recovered" and all described as "Caller added he was diagnosed with COVID-19 infection last week."; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever".  Follow-up (30Dec2021): This is a spontaneous follow-up report from same contactable consumer.  Updated information: patient details include age, height, weight, 1st dose details and events was added. Additional information: N/A  Follow-up (03JAN2022): Follow-up attempts are completed. No further information is expected.
patient developed an all-over body rash approximately 48 hours after the new spikevax moderna vaccine -- itchy -- will follow up with md if it gets any worse
Initially, diffuse skin burning, malaise, chills, fatigue. After 2 days, area at medial left elbow and volar surface of right forearm had burning pain and hyperesthesia that has persisted till present day. No rash. Skin tender in these areas.
A spontaneous report was received from a consumer concerning a 30-year-old, female patient who experienced dizziness, pain and palpiations.   Patient's medical history was not provided. Concomitant medications known to have been used by the patient, within two weeks prior to the event, included vitamins.  On 05 JAN 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6th JAN 2021, the patient reported dizziness, body pain with high palpitations.  Treatments of the events were not provided.  Action taken with mRNA-1273 was not reported.  The outcome of the events, dizziness and body pain with high palpitation was resolving.; Reporter'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.
The patient started with severe pain at pneumonia injection site, left arm.  Pain was in entire arm. elevated pain (like childbirth), stiff arm (like paralyzed), shaky body.  Patient could not move her arm.  About 1 - 2 hours later she took Ibuprofen, and the pain decreased.  The next day decreased appetite, decreased pain, nausea, faint, exhausted, sore arm, no redness or swelling.  Unable to lift arm, depression.  After 1 -2 days all okay except the patient had a sore arm.
Event Syncope: Paleness, Nausea, Dizziness, Fainting, and Visual Disturbance. Patient Fainted, but regained consciousness with a few seconds. I had patient lie on the ground with blanket and pillow underneath, provided cold compress on head, neck, and injection site. I also provide OJ to increase patients blood sugar. I monitored patient for 30 to 45 minutes, notified family via phone. Once patient was stable patient returned home, I contacted patient at 11:31 AM, to make sure patient was home safe and told her to rest for the day. Patient was informed to call Pharmacy or PCP if any further reactions. Also she can take Tylenol or Motrin for injection site soreness.
AFTER RECIEVING THE SHOT, WITHIN 5-7 MINS, PATIENT EXPERIENCED SYNCOPY AND FELL TO THE FLOOR. ON THE WAY, SHE HIT HER HEAD AGAINST THE WALL.  SHE WAS TURNED OVER AND SHE STARTED TO SEIZURE FOR ABOUT 10 - 15 SECONDS THEN SHE REGAINED CONCIOUSNESS WITHIN 5 MINUTES.  911 WAS CONTACTED AND SHE WAS TAKEN TO ER FOR FURTHUR EVALUATION.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 40-year-old female patient (not pregnant) received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), intramuscularly, in arm left, on Nov 30, 2021, single dose, for COVID-19 immunisation. Medical history included allergy to sulfa (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty), for COVID-19 immunization. The patient reported immunization/booster/dose 3, onset Nov 30, 2021, with outcome of unknown; and pain/achiness, onset Dec 1, 2021, with outcome of recovering. No therapeutic measures taken as a result of pain. Additional information: Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, patient has not tested for COVID-19. The lot number for BNT162B2, not provided and will be requested during follow-up.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild
Vaccine Hep B (#3) given at 13:30 01/19/03.  States awoke at 1:00am with high fever and chills and nausea and vomiting.  Fever lasted 3 hours.  Was unable to go to work next day due to general body aches.  3rd day asymptomatic.  Return to work with problems.
Pt recvd vax 9JUN92 & later exp joint pain involving fingers, hands, wrists, knees & elbows; 23JUN92 exp a stiff neck, back pain, myalgias & arthralgias; presented to ER for tx;
Starting the evening of the vaccine, I started to experience mouth tingling/numbness. THe following morning and onward, I can no longer taste
I had my baby in August 24, 2020  so I wasn't sure if this was normal.  I got my period right after the first shot and it was pretty normal except bleeding a bit longer than usual and subsequent periods everything lasted longer including the cramps, mood swings, bleeding, bloating, and swelling. The most erratic period was the one I had in May which was one month after the 2nd vaccine where I had cramping that lasted 4 days before my period started. The period lasted 4-5 days. Subsequent periods, I've had days of cramping, usually a couple of days, and then the period starts and that was never the case for me before taking Pfizer. When I brought my son in for his wellness check I spoke to my Doctor about it and I talked to my gynecologist too and they said at my age that they're not going to do much but I can go on hormonal birth control or do an ablation but we're not sure if we want more kids or not so I did not take them up on that so I just take ibuprofen.
covid test result=Positive / covid test date=02Jan2022; covid test result=Positive / covid test date=02Jan2022; skin on my face and hands dried out so bad that it started peeling and burning; skin on my face and hands dried out so bad that it started peeling and burning; skin on my face and hands dried out so bad that it started peeling and burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Sep2021 13:00 (Lot number: 30130BA) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; TRESIBA; PHENTERMINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "covid test result=Positive / covid test date=02Jan2022"; DRY SKIN (non-serious), SKIN BURNING SENSATION (non-serious), SKIN EXFOLIATION (non-serious) all with onset 12Sep2021, outcome "not recovered" and all described as "skin on my face and hands dried out so bad that it started peeling and burning". The event "skin on my face and hands dried out so bad that it started peeling and burning", "skin on my face and hands dried out so bad that it started peeling and burning" and "skin on my face and hands dried out so bad that it started peeling and burning" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive. Therapeutic measures were not taken as a result of dry skin, skin burning sensation, skin exfoliation. Clinical course: The reporter stated that it did not occur until 4 days after initial dose. She further stated that her skin on her face and hands dried out so bad that it started peeling and burning. She stated that nothing made it better, still to this day on 15Feb2022 her face and hands had gotten progressively worse. She stated that she could not wear any makeup at all because her skin was constantly peeling and having red rashes show up. No vaccine in four weeks. No covid prior vaccination. No Known allergies. She stated that she tested for Covid test post vaccination (Covid test type post vaccination was Nasal swab) on 02Jan2022 tested for Covid and got the Covid test result Positive.  No follow-up attempts are possible. No further information is expected.
At night, throat felt swollen as if she had a lump in it.  Next morning, also had red, puffy eyes and throat still felt as if it was swelling; was concerned that if it continued, she would have difficulty breathing.
Nausea, vomiting, diarrhea, sweating, chills, fever, body aches - lasting 30+ hours.
Shingles; This is a spontaneous report from a contactable consumer. This report 2 of 3. This case is for the 2nd stepdaughter.  A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Family History included Rheumatoid Arthritis (mom). The patient's concomitant medications were not reported. The reporter does not believe she had any other vaccines, but she does not know. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Reporter does not know when she had her first dose of the vaccine. It was the Pfizer version and believes she had her second dose, but she was not 100% sure. She does not know in which arm she got it. The reporter has 2 stepdaughters. They both received the Pfizer Covid Vaccine, and they both have developed shingles on an unspecified date. It was quite a few weeks after they got the injection. The reporter was not sure of the timing. They suspect it may be related to the vaccine. She is a nurse. She got the Covid Vaccine before most people in her country. She wanted to get protected for herself as well as for her clients. The reporter thinks it was a few months later that she developed Shingles. The reporter thought it was strange that the patient and her sister both had shingles at such a young age. The reporter does not really remember when the Shingles started for her. It was about 2 or 3 months ago. It has resolved. The reporter does not know when it resolved. It was unknown if event required a visit to Emergency Room or Physician Office. The outcome of event was recovered on an unknown date.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021797564 similar report from same reporter/event/drug, different patient
blister on the elbow of the same arm in which the vaccine was administered; This is a spontaneous report received from RA. A contactable pharmacist reported on behalf of an unknown consumer (patient). A patient of unspecified age and gender received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Feb2021 10:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had developed a blister on the elbow of the same arm in which the vaccine had been administered on 25Feb2021 14:00. The blister resolved prior to the patient's appointment with a physician, which was approximately one week after the vaccine dose. The outcome of the event was recovered on an unknown date in Mar 2021.  Follow-up attempts completed. No further information expected.
Client had received Moderna as primary series. Client requested Moderna vaccine as booster. Pfizer vaccine was given in error.
Sometime after receiving the second dose, fingernails have developed what appears to be Nail Psoriasis to the point that on 6/21/2021 the patient ran out of functional fingernails as they had wasted away.  This was reported to Moderna and again updated 7/14/2021 after the patient visited a dermatologist who suspects Nail Psoriasis.  Samples were takens to see if Fungal issues are also involved.  In AAD brochure, Causes of Psoriasis is suspected to be mistakenly activating T cells, triggering inflation.  A trigger is often described as setting off the Psoriasis.  The patient had never had nail psoriasis but some indicators and family history.  In that the COVID 19 Vaccine is described as impacting T Cells/Immune system, the correlation seems possible.
pt recv vax & w/in 24hr post vax pt exp inflamed tonsils, pharyngitis, anterior & posterior lymphadenopathy & elevated liver enzymes;MD visit was required Trimox had been prescribed for pharyngitis w/o effect;sx cont
About 5 days after I received my injection, my blood pressure went to 170/ 100 for about 2 -3 hours. I was kept one night at the hospital due to an image of my lungs.  My blood pressure had been good and it still has not come down.  I am not sure if this is due to injection or not.
Patient noted on flu shot form that ZOSTAVAX irritated psoriasis; following ZOSTAVAX, the next morning pt experienced blisters, redness, rash on feet/she discussed at appt w/dr. she had already made that morning and currently under her care 1 month later psoriasis flared up and currently treating w/medication and light therapy (pt stated not sure if this is due to vaccine as well) but noted it on flu shot form.
Patient came into the pharmacy on 9/25/17 with swollen, red, hot, puffy left arm. Patient reported that both vaccines were given in the left arm. Pharmacist recommend that patient takes BENADRYL and check with MD. Patient took prednisone and arm was back to normal on 9/27/17.
1st dose 3 years ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (first dose of Shingrix series recived about 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 02-MAR-2023 Reporter comment: The pharmacist stated she has a patient that reports receiving first dose of Shingrix series about 3 years ago, and has not yet received the second dose.   The patient is scheduled to come in for dosing on 10th March 2023.   The pharmacist does not have on record the exact date of the first dose, and does not have the lot number / expiration date information. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.