chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Daptacel was given to a patient/No AE; Initial information was  received on 27-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old female patient who was administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 27-Feb-2020, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5366 AA, expiry date: 07-Feb-2020) via an intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  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.
On way home after receiving VARIVAX #2 pt developed blotchy, itchy red rash on face & trunk along with vomiting. Pt called office & was advised to seek medical attention.
A nurse reported that an 86 year old male received an injection of Flu Shield (2001-2002 formula) on 18-Nov-2001. Approximately 12 hours post-vaccination, the patient developed a rash on his chest, back and arms. He also developed a reddened face. The patient was treated with Benadryl (diphenhyramine)
July 15,2021 I started noticing my leg was swollen. That lasted for 5 days. On the 21st I went to the doctor to get an ultrasound. I was rushed to the hospital I had to get an acute DDV. Stayed over in the hospital. On the 27th I got a ultrasound. They found blood clot in the lungs and right leg, large lymph node in pelvic area.  Diagnosis with cancer and blood clots cause of restricted blood flow
Patient describes at the site of injection the following symptoms: tenderness, black and blue discoloration (like a bruise but no history of trauma to arm since vaccine injection), site feels hard but not warm.
The patient should have been given 0.5 mL of the vaccine solution for a "full dose" but instead was only given 0.25 mL or a "half dose". She contacted our office on 4/14/22 when she became aware of the dose mix-up.
Leg paralysis that started in the toes and over a couple of days progressed up both legs into the thigh. Was admitted to the ER where I was given a LP to check for GBS. I was then told that I had Guillian Barre Syndrome and that I should undergo IVIG Treatments . I was admitted to a room from the ER and was given IVIG for 5 days. After day 3-4 the paralysis started to reverse and 90% of the feeling in my legs came back. I still have numbness and little control of my left foot, knee and ankle. The right leg is back to normal.  I have been unable to walk without wearing a PHAT brace. I am back to work on light duty permanently. Also have Bladder issues since the GBS, and some neuro issues.
breast pain; pain in the back of the injection arm; pain in the arm pit; injection arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (breast pain), PAIN IN EXTREMITY (pain in the back of the injection arm), AXILLARY PAIN (pain in the arm pit) and VACCINATION SITE PAIN (injection arm soreness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMINES AND MINERALS for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection arm soreness). On 19-Mar-2021, the patient experienced BREAST PAIN (breast pain), PAIN IN EXTREMITY (pain in the back of the injection arm) and AXILLARY PAIN (pain in the arm pit). On 14-Mar-2021, VACCINATION SITE PAIN (injection arm soreness) had resolved. At the time of the report, BREAST PAIN (breast pain), PAIN IN EXTREMITY (pain in the back of the injection arm) and AXILLARY PAIN (pain in the arm pit) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD21-077255 (E2B Linked Report).; Sender's Comments:  MOD21-077255:
Started 3-4 days post-vaccine with left axillary adenopathy with tenderness and swelling. Now with bilateral wrist pain and erythema.
So, I started to bleed heavily, like worse than a normal menstrual cycle, I was not supposed to be bleeding at all, I was not having a cycle at this time because of the medication I was on, the bleeding began and it was very bad, I was bleeding through tampons, pads and my clothing.  I was in treatment at this time and this part had stopped so I was concerned because it was very heavy, I had blood clots an all.  I called the doctor and let her know what was going on and she did an internal ultrasound to check the lining of my uterus and to see if I had any cist on my ovaries. Dr. saw that the treatment was working, and the doctor asked did I get the vaccine and I told her yes, and she advised that this was just a side effect from the vaccine, and that it should stop.  Advised that I began taking my iron supplements again for the fatigue and it did stop eventually.
Redness, warmth, weeping blisters - all over 2 day time frame. Treated with KEFLEX 30 mg/kg/day divided into 3 doses over 10 days.
Denied any problems with previous immunizations and was well at time of vaccination. He reported the onset of swelling to vaccination site on the same day. He stated the area was red, hard like a rock, painful and warm to touch. It reached a size 3 inches and did not extend below elbow. He also reported that he felt fatigued, weak and had multiple joint discomfort. He did take anything for the discomfort and all symptoms completely resolved within one week.
Information has been received from a consumer concerning her 7 year old son with no pertinent medical history or drug allergies who on 15-AUG-2001 and 27-AUG-2007 was vaccinated with his first and second dose of varicella virus vaccine live (Oka/Merck) (lot number not available). Concomitant therapy included "unspecified antibiotics." On 17-SEP-2007 the patient developed a mild case of chickenpox. No medical attention was sought. No lab or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information has been received from a physician's office indicating that the patient did not have an adverse event from the first SC dose of varicella virus vaccine live (Oka/Merck) (lot# 638818/0499L) in the right arm or the second SC dose in the left arm. No documentation of an event was in the patient's chart. This is one of several reports from the same source. Additional information has been requested.
Felt weak; Skin turned red; Hands turned red; Nausea; Sweating; Flushing; Red ring around injection site; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), FLUSHING (Flushing), ASTHENIA (Felt weak), ERYTHEMA (Skin turned red) and ERYTHEMA (Hands turned red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red ring around injection site). On 24-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), FLUSHING (Flushing) and NAUSEA (Nausea). On an unknown date, the patient experienced ASTHENIA (Felt weak), ERYTHEMA (Skin turned red) and ERYTHEMA (Hands turned red). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), FLUSHING (Flushing), ASTHENIA (Felt weak), ERYTHEMA (Skin turned red), ERYTHEMA (Hands turned red), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Red ring around injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Headache, Myalgia, Arthralgia, Fever, FATIGUE, CHILLS, SHIVERING Narrative:
Patient presented to our pharmacy on July 24, 2021 requesting the Janssen Covid-19 vaccine. Upon review of his paperwork, he reported never receiving a Covid-19 vaccine prior to this date. When was reviewed, he did not have a profile or any vaccine listed. Upon billing the patient's insurance at a later date, we received a rejection that the patient received a different Covid-19 vaccine at a different pharmacy on July 22, 2021. We contacted the insurance, and they stated the other billing pharmacy. We contacted that pharmacy to confirm the vaccine was administered to the same patient on that date and not a spouse or other household member with the same insurance. They verified this information and stated the patient received his first dose of Pfizer vaccine on July 22, 2021 and there is usually a delay in their reporting time due to corporate reporting structure. Patient has not reported any adverse events after vaccine administration.
The booster dose of Pediatric Pfizer (5-11 years) was given to patient on 10/03/2022. The information that we perceived at the time was: expiration date 10/31/2022 (based on manufactured date 10/2021), and beyond use date was 10 weeks from fridge date (fridge date was 08/22/2022, BUD is 10/31/2022). The information to recall was received on 10/12/2022 and the product was isolated on the date of.
on 21Aug2021, the patient experienced LINGERING COVID ISSUES; on 21Aug2021, the patient experienced LINGERING COVID ISSUES; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388298-00 (Agency).  A 49-year-old female patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. 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 21Aug2021, outcome "unknown" and all described as "on 21Aug2021, the patient experienced LINGERING COVID ISSUES". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Spots on her brain, notes: Spots on her brain; Weight: Sixty pound weight loss, notes: Sixty pound weight loss. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "on 21aug2021, the patient experienced lingering covid issues" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality:  Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB)   COVID-19  (COVID-19)   Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported  De challenge: N/A  Seq.No. 2 Drug: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) )(TOZINAMERAN)Unknown, Un-known, Unknown  Causality: .COVID-19  (COVID-19)   Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available possible contributory role of the suspect  BNT162b2   cannot be excluded for the reported events of drug ineffective,covid-19.
after taking the first dose of the Moderna vaccine, 5 day later my mother began to see redness appear on arm. she went to the doctor and they explained to her it is called Covid Arm and will go away within48 hours. It has now been 6 days and it is only getting bigger.     the doctor circled it and said if it gets any bigger she will place her on antibiotics, she is now taking antibotics and saw another docter who said to take antihistamine  and place a topical cream on the reaction.
Fever from 38 C to 38.4 C between 3pm on 5/21/21, to 2am on 5/22/21.  Also had body aches all over (ribs, legs, arms, back), general fatigue. Treated with acetaminophen (325 mg) at 2am on  5/22/21; temperature decreased to 37.5C by 5/22/21 at 7:00am, and temperature increased to 38.0 on 5/22/21 at 11am.  Treated with acetaminophen (325 mg) at 11:47am on  5/22/21; temperature decreased to 37.6C by 5/22/21 at 1pm.  Same body aches and fatigue persisted.
A blister similar to chicken pox blister appeared on the right arm. He had a terrible stomach ache and wanted to be held with tummy pressed all the time. He never slept in the night after this- non-stop crying. He had a high fever, we gave him tylenol. After that, slowly he regressed, quit responding to his name, stopped eating and went into the world of autism. He was developing normally until then.  5/22/08 MR received for multi-disciplinary diagnostic testing for Autism 10/25/07-12/14/07 with DX: Autistic Spectrum Disorder and mental retardation.  Developmental delays noted in receptive/expressive language and social development as well as cognitive ability. 1/21/2010 He is still vaccine damaged, non-verbal and autistic.
no adverse effect; second dose received after 5 years of interval; This spontaneous report as received from a healthcare student refers to a 18 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      Approximately in 2014 (reported as 5 years ago) and subsequently on 13-NOV-2019, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R026716, expiry date : 30-MAY-2021, intramuscularly) for prophylaxis (inappropriate schedule of product administration). No adverse events were reported.
30 min after shot my lips and fingers began to tingle. After 5-10 min there was a bitter taste in my mouth. Lips and mouth then felt numb and I had difficulty swallowing.  At 10 hours post shot body aches, EXTREME  headache, ringing in ears, blurred vision, dizziness,  heart beat seemed fast and some times irregular,  chills then sweating.  24 hours after shot the headache and body aches are mild. I am fatigued.
Severe fever (103.7) body aches, light sensitivity,  nausea, diarrhea. symptoms lasted for 72 hours
Red, raised rash on lower back 24 hours after vaccination. Warm, red, tender area left arm, deltoid region. Dry cough, "runny nose" and anorexia (poor appetite).
I was very dizzy I had vertigo, just not feeling well. I had to go to the urgent care and call her doctor, they couldn't find the right issue and said it might be vertigo and it went away within a week.
Didn't feel well this am 4/9/21, not able to eat lunch or take meds; approx. 3 pm started feeling weak, chills, headache, stiff neck, severe body aches, nausea.  Presented to the unit clinic at 1600 and temp was 103 degrees, pulse 123, resp 18, b/p 161/97
Syncope (began profusely sweating, felt nauseous, tunnel vision). Was sitting down to prevent fainting, but still lost consciousness for about 30 seconds. When I came to, I was sweating even more profusely followed by chills.
The subject of this report is actually the pharmacy technician who was giving a vaccine to another patient. She administered the vaccine to the patient and then accidentally dropped the syringe, giving herself a needle stick in her left leg. This report is to document the needle stick.
Hive reaction around vaccine site. Administered PO 7.5ml of BENADRYL and 15 min observation.
Injection site pain, mild Headache, moderate  Chills, mild Muscle and joint pain, moderate
I got vaccined  for the first time on January the 12th of 2023 at supermarket Pharmacy.  On January the 30th of 2023  (18 days later) I started bleeding (as a regular period).  However, I had early menopause when I was 42 years old, so I?m not having my period for 5 YEARS ( I?m 47 years old now).  Today January 31st of 2023, I still bleeding, felling cramps and pelvic pain.   Ps.: I got Covid -Omicron on December 2022 , with almost no  symptoms, I recovered pretty well and NO SIDE EFFECTS at all !!
I have pressure in my ears, it feels like an ear infection but its not. The pressure hasn't gone away, my regular doctor saw me and sent me to an EMT but found nothing abnormal. I was tested and everything came back fine. I was prescribes steroids', Mucinex and nasal spray but nothing worked.
hives all over her body/hives/rash; hives/rash; This is a spontaneous report from a contactable Other Health Professional. A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left at the age of 12-year-old on 28Jun2021 (Lot Number: EW0191) as single dose for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. The patient previously took first dose bnt162b2 (Lot EW0186, First administered in the Left Deltoid) at the age of 12-year-old on 04Jun2021 for COVID-19 immunisation. The patient got the first dose of the Pfizer covid vaccine and after the first dose had broken out into hives from head to toe, she is wondering if it is safe to administer the second dose to the patient. Caller states that a patient received her first and second dose of the Pfizer Covid-19 vaccine, but after the second dose, the patient had hives all over her body. Caller asks, ''if a booster shot is proven to be needed later in time such as in the fall, should the patient not get it?'' When queried first dose date of the patient, at first the caller states that she is not sure, one of her other representatives put second covid vaccine dose as 28Jun2021 and because of that she is not sure. Caller is aware that the hives/rash began a couple hours later after she had the covid vaccine and she has had them all day. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. ''Later on in the call, caller is able to confirm first and second dose. Caller asks for this age group is it just 2 doses or do they require a booster? Caller confirms that the first dose was given on 04Jun2021 and the second dose was given on 28Jun2021. Caller states the reason she was asking if its okay to give another is because the parent of the patient was asking if she would still get the next dose. Caller states that since the patient has already received 2 doses she is not sure why the parent was asking about another dose, caller then asks if this age group will need a 3rd shot as a booster?  '' Caller is aware that the hives/rash began a couple hours later after she had the covid vaccine and she has had them all day on 28Jun2021. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. Therapeutic measures were taken as a result of events. The outcome of events was not recovered.
Low grade fever which was 2 degrees above normal; A tiny heat rash can't seam to get rid off; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that she was perfectly fine after getting the first shot of the Covid vaccine and on an unspecified date patient had a low grade fever which was 2 degrees above normal and until today she added that she still has fever. Also has a tiny heat rash on an unspecified date, can't seam to get rid off. Outcome of the event low grade fever was not recovered and another event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 hours post immunization patient presented with an 8.5 cm x 11 cm indurated area of erythema and warmth. Mild pain wiht moving (R) arm.
On Friday October 8, 2021 had low grade temp and right sacroiliac area pain and unable to walk. As of Tuesday October 12, 2021 still have pain in the right sacroiliac area. No temp
Weakness and discomfort (L) arm since. She received vaccine, first visit to provider since vaccine administered unable to do resistance traveling with out pain and weakness.
Patient experience flare of lichen sclerosis. Reports having had very brief flare (1 day of pain and redness) after first dose, but second dose had flare requiring increased frequency of topical steroid (from 3x/wk to daily for two weeks), and will be returning to gynecology for management of flare.
General side effects after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (General side effects after 1st and 2nd dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (General side effects after 1st and 2nd dose). At the time of the report, VACCINATION COMPLICATION (General side effects after 1st and 2nd dose) outcome was unknown.            Patient stated that she is not on any concomitant medications and it was unspecified after dose-2 or booster dose. Patient stated that the side effects are relatively under control and it was unspecified clearly, whether this side effects belongs to dose-1, 2 side effects or after booster dose side effects. Patient also reported that she got covid as she tested positive on 27Dec2021 and stated is coughing and mentioned that side effects even more frustrating.   This case was linked to MOD-2022-439467, MOD-2022-439047 (Patient Link).
Dizziness about 30 minutes after.  Approximately 6 hours after the  injection site turned red, very swollen, very painful, difficult to lift and move arm and very sore to touch or apply pressure.   Approximately 10 hours after the injection began having COVID symptoms with fever of 102.1, all over body aches, headache, nausea, very fatigued, dry mouth, itchy eyes and eye drainage, neck pain and tenderness on the left side and pain and swelling running up left arm into shoulders and neck.   Also, my right arm was very sore and tender in the exact same spot as my left arm injection site.  Pain in left jaw and teeth and right groin area. As of 26 hours later I have the same symptoms as listed above and my head feels very heavy like I can?t hold it up.
The patient developed blood cloths in the brain as informed by the caregiver after an MRI.