chrisvoncsefalvay/vaers-outcomes huggingface dataset:
in error gave a dose of pentacel to a 4 month old patient that had been drawn up 16 hours previously, it should have been discarded when not used within 30 min due to the lyophilized act hib component, no advesre event; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a four months old patient (gender not reported) who was vaccinated with a dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which had been drawn up 16 hours previously, it should have been discarded when not used within 30 min due to the lyophilized Act-Hib (lot number and other dosing details were not reported) on an unknown date.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to Wrong technique in product usage process.  No adverse event reported at the time of reporting.  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.  Information on the batch number was requested.
Really sore Arm; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Really sore Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient experienced MYALGIA (Really sore Arm). At the time of the report, MYALGIA (Really sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's wife reported that he had a scheduled oncology appointment. No concomitant medications provided. No treatment information provided.
Pt received vaccine in office, checked out an went to Radiology office for X rays while waiting at that office, experienced itching and SOB had X rays and when got home, realized she had hives and felt throat tightness called my office and was directed to take Benadryl 25mg symptoms resolved in 2 hrs.
Patient admitted as observation on 4/11 due to acute-on-chronic kidney injury likely pre renal with recent medication changes. Patient was tested for COVID-19 and was positive on 4/11.
This is the reaction to the second dose of Covid-19 Moderna. Just like with the first dose I got the 'Covid Arm'. The rash was longer, all along the biceps brachi.  The 'Covid arm' didn't  itch.  But I got again itching rashes in the upper body: head, face and neck. These latter where less prominent and the itching milder than the first dose. As with the first dose I applied to the arm rash Hydrocortisone cream USP 2.5%. Stopped using the cream after the 8th day since the rash is fading away.  It's been 12 days since I got this second dose and so far have no other reaction.
VACCINES EXPOSED TO TEMP OUTSIDE OF REC STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
Headache, Myalgia, Fever, FATIGUE/CHILLS/LYMPH NODES SWOLLEN IN NECK Narrative:
Mild fever; Sore arm; Difficulty sleeping; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty sleeping), VACCINATION SITE PAIN (Pain at injection site) and PYREXIA (Mild fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported.).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced INSOMNIA (Difficulty sleeping) and VACCINATION SITE PAIN (Pain at injection site). On 12-Jan-2021, the patient experienced PYREXIA (Mild fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Difficulty sleeping), VACCINATION SITE PAIN (Pain at injection site) and PYREXIA (Mild fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment medication included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Low blood sugar 43 per EMS-Severe
Admitted to Hospital on Date of Adverse Event [recorded in agency] for treatment of Covid-19 Positive following completion of Covid Vaccine Series
A few days after pt received flu vaccine, she complained pain and numbness on her left arm. Rash & numbness never went away ever since.
I was having nasal congestion, a headache, body aches, and very fatigued. I took a COIVD-19 at Home Test and it was negative. I was still feeling poorly the next day and took another home test which was also negative but I was getting worse so that did not make sense to me. I went in to get a COVID-19 PCR Test that Sunday at my pharmacy. The fatigue was worse and I was just feeling worse. At that point I did a telehealth appointment and they said it must be a sinus infection and got an antibiotic. I still was not doing any better and I got another COVID-19 PCR test and it was positive. I also want to include that I had had hearing loss my entire life which I lost when I was child after having the mumps- while I had COVID-19 I was cleaning that left ear and I was able to hear the qtip in my ear. I have not been able hear anything my whole life but am following to do a hearing test and possibly get a hearing aid if I am able to now hear in that ear that I have never been able to hear in and have even tested many times over my life without ever hearing anything.
Severe headache on upper left side of head (lasted 18 hours) took extra strength Tylenol every 4 hours and would not go away Severe nausea for 18 hours on and off (mostly on) Confusion/disorientation (only lasted 5 minutes) Freezing and chills- could not get warm even with heating pads
Dizziness, Headache, Arthralgia & NauseaVomiting Narrative:   Other Relevant History:
patient described her arm being swollen and painful/red/hot to the touch. tried taking tylenol, applying ice and it was unhelpful-she stated that she couldn't have movement in her arm until yesterday and was very fatigued (6 total days). she requested we submit this vaers even though she read all the adverse events were as expected.
Disequilibrium of unknown origin post vaccine as well has chronic pressure headache, lightheadedness, and presyncope episodes.
Information has been received from a physician concerning a 19 year old female with no pertinent medical history who was vaccinated with two doses of the Gardasil (dates not specified). Concomitant therapy included Yasmin. Subsequently, the patient testes positive for human papilloma virus (HPV) with the HPV DNA test. The patient had not experienced any known symptoms. Patient outcome was unknown. Additional information has been requested.
Onset 8/7 - erythema, itching, given Benadryl; 4cm with 2cm raised area centrally at back of deltoid surrounding puncture mark
Swelling in my rt breast; 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 BREAST SWELLING (Swelling in my rt breast) in an 85-year-old patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BREAST SWELLING (Swelling in my rt breast). At the time of the report, BREAST SWELLING (Swelling in my rt breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided No treatment medications were provided   Reporter did not allow further contact
Right arm of injection developed a large red, circular raised rash below the injection site (at the injection a small red circle formed on the skin which turned into a bruise later).  Under both the injection site and the larger circular rash, lumps could be felt.  These lumps went away after several days and the rash appeared also to be going away.  However, on Day 13, the large, red circular rash under the injection site seemed to grow larger and changed insofar as the boundaries of the rash became raised.  The rash is hot to the touch and is somewhat itchy.
PATIENT STATED THAT THE NEXT DAY AFTER RECEIVING THE SHOT SHE GOT A LARGE RED CIRCLE AROUND THE INJECTION SITE THEN IT STARTED TO GO AWAY BUT ON 4/7/22 SHE DEVELOPED A BLOTCHY REDNESS AROUND THE AREA WHICH SHE STATED HURT A LITTLE AND WAS A LITTLE ITCHY.
Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: No new information. On 20-Jul-2021: TCR Received-Non Significant FU-Denied Further Followup
Shingles. A rash with oozing blisters still hurting and open 10 days after dose II I read about the Israeli study and I don't think it's a coincidence. I have never suffered from this before.
severe head injury; This is a spontaneous report from a contactable consumer. A 92-year-old male patient received the first dose of BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had first shot on 09Feb2021 and missed second dose (02Mar2021) because he had been hospitalized for severe head injury from 28Feb2021. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Initial reaction within the hour, dizziness.  6.5 hours later, heart pounding so hard that it woke me up from a sound sleep.  Erratic heart beating for 30 hours and residual effects for 2 weeks.  Palpitations, skipping beats.  In addition, the first 30 hours included Hugh fever, sweats, chills, shivering.  Dizziness, ears ringing, head noises, shortness of breath, exhaustion.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Pruritic rash, 45 min. after shot. No SOB or swelling.
Jansen COVID-19 Vaccine EAU Headache, nausea, shortness of breath, weakness, extreme tiredness, fever, body aches and joint pain all over, cold sweats started about 7 hours after shot. The next day fever and headache were gone but other side effects stayed all day. Today side effects are still here but much less than yesterday.
Within 30 minutes,  I had  excruciating pain in my lower back, I could not bent, twist, or lift anything.   The pain lasted 2 days.  I also had chills, fever, and body ache at night time.  My temperature went up to 100.5 and at the time of this reporting  it was 99.4.  I took advil to ease the pain and lower the fever.  My back is till a little sore and I have a light headache the day after the injection.
Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17   Rapid response team arrived at 427pm.    429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.
I don't know if I marked the right vaccine.  Al I know is that I received a flu shot.  Severe facial swelling of lips and left eye and cheek.  Swelling started in the middle of the night after the day in which I received the vaccine.  I had the vaccine around lunchtime and woke in the night and felt swelling on my face.
5" area of redness, slight warmth and tenderness, medial to and around injection site.
Headache; Tired; Hands started shaking really bad; Nauseated; Threw up; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6200) intramuscularly, administered in right arm on 21Feb2021 at 10:15 (at the age of 74-year-old) as dose 2, single for COVID-19 immunisation. Medical history included breast cancer (She had breast cancer and did have radiation 2 years ago). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. The patient previously took first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262) intramuscularly, administered in right arm on 31Jan2021 (at the age of 74-year-old) as dose 1, single for covid-19 immunization and she felt really, really tired like she was fatigued and could hardly go. On an unspecified date in Feb2021 the patient experienced headache, tired, hands started shaking really bad, nauseated and threw up. It was reported that she had her second vaccine yesterday. She had a terrible headache, and she went to bed early because she was really tired. She woke up around 2:30 a.m., and her hands started shaking really bad. The shaking stopped. Then this morning when she woke up again, she was nauseated, and she felt like she was going to throw up. She did in fact in throw up. She still has a little bit of a headache. The event hands started shaking really bad was recovered on unknown date in Feb2021 and headache was not recovered. Outcome of the other events was unknown.   Follow-up attempts completed. No further information expected.
Rash at the injection site; Rash travelling to the arm and wrist and hand; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash at the injection site) and RASH (Rash travelling to the arm and wrist and hand) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site) and RASH (Rash travelling to the arm and wrist and hand). At the time of the report, INJECTION SITE RASH (Rash at the injection site) and RASH (Rash travelling to the arm and wrist and hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
clinic administered 65,000 DTP doses to date; 1 of 21 pts exp fever of 105.2 evening p/DTP/HIB vax; became fussy & irritable; fever ranged from 102 to 105 for 2 days; recovered;
Shortness of breathe. Chest pain. Go to ER. Concerning EKG. Ultrasound on heart is OK. Blood is drawn and is concluded to be OK. Lung x-rays taken and determined to be ok. I was then informed of pericarditis and prescribed ibuprofen for the inflammation.
Individual was talking about (believed) her dad who has covid.; Individual was talking about (believed) her dad who has covid.; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "Individual was talking about (believed) her dad who has covid."; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "tired". The patient did not loose taste or smell but just tired. Caught it believe about a week ago. The lot number for bnt162b2 was not provided and will be requested during follow up.
During the night after the vaccine I experienced body ache, fever, chills, sweats, and headache. This lasted for 1 1/2 days.
Left hand paralysis and numbness; Left hand paralysis and numbness; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Left hand paralysis and numbness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced MONOPLEGIA (Left hand paralysis and numbness) (seriousness criterion medically significant) and HYPOAESTHESIA (Left hand paralysis and numbness). At the time of the report, MONOPLEGIA (Left hand paralysis and numbness) and HYPOAESTHESIA (Left hand paralysis and numbness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, X-ray: inconclusive (Inconclusive) No conclusive diagnosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  Company Comment: 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received first dose of Moderna COVID 19 vaccine on 6/5/21 and second dose on 6/24/21.  Second dose was given too soon; prior to 28 days and prior to the 4 day grace period.
Swelling and throbbing on upper right arm with deep intense pain per patient. Pt self treated with Benadryl that night. AM 6/14/2014 awoke with severe headache- rest to treat.
Patient reported two bouts of diarrhea and nausea since receiving her two vaccinations.
Left arm tenderness, swelling, and warmth at the site of the injection for Varicella vaccine that was administered 2 days ago. Denies any swelling in any other part of arm, difficulty breathing, or SOB. Informed ppt that this is a normal reaction to the VZV and recommended applying ice compresses to the area 2-3x/day and take ibuprofen OTC to assist with discomfort and swelling. Instructed to go to the ER with any SOB, difficulty breathing, or tongue swelling. Pt verbalized understanding of info provided.
Extreme loss of strength and energy at 2pm followed by  and hour long bout of chills and uncontrolled shaking  starting at about 9:15pm.  On the following day  (2/24) I felt extremely weak and fainted at about 7:00am.  So weak it took about 15 minutes before I could raise myself up from the floor.  Felt weak and unsteady all day and had muscle aches all over.  Slept on and off for most of the day.
Pt had Varivax on 01/26/01. Developed chicken pox 06/21/02.
Fever of 101, muscle aches, headache, and blacking out unable to walk.
Mom described red and swollen left thigh, 1 week after receiving 4 vaccines in left thigh with generalized rash. No fever and swelling resolved. MD observed thigh, 3 weeks after injections and swelling was resolved.
Feeling tired; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows:  The patient reported the case for himself/herself. The age at vaccination was not reported. On the day before reporting date, the patient had received first dose of Shingrix and was feeling tired. The patient inquired that was this normal. No other information was reported.
Pt almost immediately began to feel warm all over. Her face, ears burning and warm. Spreading to her chest. No c/o SOB or tongue swelling. Pulse ox 99-100%. HR 88 BP elevated at 176/104. She c/o of feeling jittery. Pt given 50 of Benedryl. Rash spread to upper arms. No rash on back or abdomen or legs. After 30 minutes, flushing less severe, Jitteriness gone, has developed a headache, still c/o some burning in her face. BP 156/93 and HR 88 PO 99%.
Initial symptoms began the evening of September 8th with chills and nausea. Symptoms progressed throughout the 9th to include hot flashes and mild fever. Symptoms continued and became more significant on the 10th with debilitating stomach pain until being admitted the evening of September 10th. CT scan was performed on abdominal area and full spectrum lab test was performed on bloodwork to confirm appendicitis. Emergent appendectomy performed the morning of September 11th.