chrisvoncsefalvay/vaers-outcomes huggingface dataset:
past due 2nd dose 64 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past due 2nd dose 64 days) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (past due 2nd dose 64 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past due 2nd dose 64 days) had resolved. Not Provided      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.   No concomitant medications were reported. Treatment information was not provided.   Reporter did not allow further contact
REDNESS AND SEVERE SWELLING THAT WENT DOWN TO HIS ELBOW AND HE DESCRIBED IT AS A BUBBLE IN HIS ELBOW. HE SAID HE HAS NEVER HAD THIS REACTION BEFORE WITH ANY VACCINATION THAT THE SWELLING GO DOWN TO HIS ELBOW AND HE COULDNT LIFT HIS ARM
I administered the Pediarix on right thigh IM.  Patient started crying lightly, not normal, I asked the mom if the cry was normal and she said yes.  I administered the 2nd immunization (HIB, IM, Right thigh) and then his breathing was very short and gasping and his face turn blue color.  Immediately called for help MD was paged.  We started placed mask O2 on infant and albuterol 2.5mg/3mL administered and pulse oximetry placed on left great toe.
weak arm; unable to lift arm; sore arm; sensation of the "liquid from the shot moving down inside arm"; This case was reported by a other health professional via call center representative and described the occurrence of instillation site abnormal sensation in a 46-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Havrix adult (intramuscular). On 7th July 2019, 52 days after receiving Havrix adult, the patient experienced pain in arm. On 8th July 2019, the patient experienced weakness of arms and injected limb mobility decreased. In July 2019, the patient experienced instillation site abnormal sensation. On an unknown date, the outcome of the instillation site abnormal sensation, pain in arm, weakness of arms and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the instillation site abnormal sensation, pain in arm, weakness of arms and injected limb mobility decreased to be related to Havrix adult.  Additional details were provided as follows: The patient was the pharmacy technician and reporter. The patient received dose of Havriix adult in right arm. 1 week after vaccination with Havrix adult, the patient experienced instillation site abnormal sensation. The patient reported that, the past sunday, from the date of reporting, she woke up and injection arm was very sore and that on the next day she was unable to lift that arm it was so sore and weak. On the day of reporting, the patient visited to the physician, and would have follow up tests to try and determine the issue. Emergency room visit required. The patient consented to follow up.
After getting the vaccine my arm was extremely sore. I got a big lump on my arm where I got the shot at. It has been 10 months and I still have a big noticeable lump in my arm.
I had a hip replacement in my left leg in 2002.  The evening that I had my vaccine I had quite a bit of pain in that hip.  It did go away by the following morning but I felt that you might want to know about it.
Prior to dilution, stored at unacceptable temperatures prior to administration. Was held at room temp longer than the recommended by manufacturer. Does was repeated.
Syncope at school on 3/12/14 no aura, no orthostatic symptoms revived by pain response. Paramedics came. Evaluated at ER. Thought secondary to dehydration.
Prior to vaccine, no ringing in ears.  Since, have SIGNIFICANT ringing in both ears.  Saw ENT and he said there was no treatment for this.  Sometimes the ringing is so loud I can't hear myself think.  But it is constant and has been since a couple weeks after second COVID shot.
SO AFTER TWO MONTHS I CAME DOWN WITH ACUTE BRONCHITIS, I HAD TO TAKE ANTIBIOTICS AND SOME OTHER MEDICINES.
Tingling, feeling faint, itchy tongue, light headed, blood pressure checks: 09:43am 150/75,  09:45am 100/70 Epipen administered. Blood pressure at 09:48am 130/82 Transported at 09:57
Shingles in 2018 got the shot to/Suspected vaccination failure; Shingles in 2018/Now the shingles is back in the same spot; Pain is some bad in my legs; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and leg pain. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the vaccination failure, shingles and leg pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and leg pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and had shingles in 2018 and now the shingles was back in the same spot the pain was some bad in legs. The patient reporter that the only thing that helped was a heat pad. The reporter did not wish the pain on no one.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
urticarial rash all over body p/16-18 hrs of vax; DPH given; pt seen again on 30JUL92 PM was given 2 shots of Epi & sent home on DPH;
Pt was vaccinated on 1/15/04. On 1/23/04 mother noticed rash (maculo papular on trunk) that extended to face and extremities. On 1/26/04 a maculo papular rash with petechia and small purpuric lesion that blanch to pressure is evidenced during office visit, also conjunctival erythema is present. No adenopathies.
Dizziness, headache, nausea following injection 2.5 weeks post injection lingering migraine, lingering fatigue, run down, brain fog, constant sick feeling, nauseated
This case was reported by a other health professional via call center representative and described the occurrence of throat irritation in a 48-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017). On 21st September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular). On 21st September 2016, 15 min after receiving FLULAVAL QUADRIVALENT, the patient experienced throat irritation, headache and postnasal drip. The patient was treated with BENADRYL. On 22nd September 2016, the outcome of the throat irritation, headache and postnasal drip were recovered/resolved. It was unknown if the reporter considered the throat irritation, headache and postnasal drip to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The reporter was a GlaxoSmithKline health care provider and an employee. At approximately 15 to 20 minutes after vaccination, the patient began to experience a scratchy throat, post nasal drip and headache. In the morning of 22nd September 2016, the patient was examined. The patient was treated with 25 mg of BENADRYL as a precaution.
Started experiencing Neurological symptoms; Essential Tremors are very prominent/Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair; body is becoming weaker by the week; The EEG is showing a slowing in her memory; She is not able to shower, dress, eat herself.; Walking-very small footsteps (shuffling); Speech-difficulty with word finding, difficulty ordering food mixes conversations; Fatigue - really tired all the time; Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out; Sleeps 9 hours at night/Feels like she can't wake up at all; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 70 years old as single dose for covid-19 immunisation.  There was no medical history.   No known allergies. No covid prior vaccination. There were no concomitant medications.  There was no other vaccine in four weeks, no other medications in two weeks. On 19Feb2021, the patient started experiencing neurological symptoms, and essential tremors were very prominent. She had rapidly declined and was now seeing a neurologist, her body was becoming weaker by the week., She's been to the Emergency Room 2 times to receive help. There wasn't much they can do to help her. She had an MRI and EEG. The EEG was showing a slowing in her memory. She was not able to shower, dress, eat herself. She was a capable women before the shot. Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair, Walking-very small footsteps (shuffling), Speech-difficulty with word finding, difficulty ordering food mixes conversations, Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out, Fatigue - really tired all the time. Sleeps 9 hours at night. Feels like she can't wake up at all. Adverse event start date was 19Feb2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received: Meds for tremors and memory issues. The outcome of events was not recovered. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Feb2021 10:00.  Information about lot/batch number has been requested.
I have had several severe headaches, i have felt lightheaded and like I would pass out.  for about the first 10 days, I had severe pain i the injection site when touched.  This was enough to wake me up if I rolled onto this arm while sleeping.  Overall, I have felt my brain is fuzzy since I had my injection.
With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area.  The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; With both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area; This is a spontaneous report from a contactable nurse. This 48-year-old female nurse reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EH9899) intramuscularly from 18Dec2020 at 12:00 pm to 18Dec2020 at 12:00 pm at single dose (dose number; 1) on left arm, then second dose, lot number; EL1283 from 07Jan2020 to 07Jan2020 (dose number; 2) at single dose on right arm for covid-19 immunization. Patient was not pregnant at the time of vaccination. Vaccine facility type was reported as hospital. Patient's medical history (If covid prior vaccination, If covid tested post vaccination; no) was not reported. Past drug included allergy; sulfa. Other vaccine in four weeks was reported as no. Concomitant medications (other medications in two weeks) included ESTRADIOL (Estrogen), progesterone and multivits. Nurse reported that on 18Dec2020 at 12:00 pm with both injections I felt an almost immediate itching on my tricep and upper latissimus dorsi area. The itching subsided on my tricep but I still have a red rash and discomfort to the lat area. Treatment was not given for the AE. Outcome of event was not recovered.
extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk; extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk; could not walk/she was not able to walk; she was not able to walk or sleep for two weeks due to the spasms and pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Apr2021 at 11:30 (Batch/Lot Number: ER8731) as single dose, for covid-19 immunization. Medical history included "gluten" (reported as past drug history), hypothyroidism, fibromyalgia, mitochondrial retrovirus and obese. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL), sertraline, colecalciferol (D3), antioxidants and "pregneolon"; all taken from unspecified dates, for unspecified indications. Patient previously took the first dose of BNT162B2 (Batch/lot number: FR2613) on 22Mar2021 in the left arm for COVID-19 immunization. On 15Apr2021 at 10:00 (three days after the second dose), patient had extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk. Her ER visit for pain yielded a script for hydromorphone and cyclobenzaprine. Even with these drugs, she was not able to walk or sleep for two weeks due to the spasms and pain. It has been three weeks since the 2nd dose, and still have limited standing time, due to the after effects. I'd get the vaccine again, but the level of pain was extremely bad.  Information on Lot/Batch number was available. Additional information has been requested.
About a few hours after receiving the vaccine I noticed swelling at the injection site the size of a quarter. Within the next 24 hours the lump doubled in size. I went to urgent care on 5/22 they measured the lump at 2 and 1/2 inch circumference. I was prescribed antibiotics cephalexin 500mg. As of today the swelling is still spreading and the lump has grown to a 3 inch circumference.
Pt. states that after receiving the 3rd dose of Phizer 12/03/2021, started experiencing symptoms 12/04/2021 of Fatigue, muscle ache, fever (99.9), joint pain, nausea, swelling at the injection site, and swelling in the face and throat. Symptoms lasting 48hrs. No noted Primary visit/communications.
pt recvd vax & 2-3 days later exp a rash on lips, arms, & legs; addtl exp welts, & knees & knuckles swelled to twice their nl size; tx Pred & Claritin; p/off meds for 2 days sxs start to reappear & c/o sl difficulty swallowing;
Afib that occurred 3 days after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: MAGNESIUM GLYCINATE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 15Dec2022, outcome "recovered", described as "Afib that occurred 3 days after vaccination". The event "afib that occurred 3 days after vaccination" required physician office visit. Therapeutic measures were not taken as a result of atrial fibrillation. Clinical course: It was unknown if Other vaccine received in four weeks, COVID tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Circular, red, inflamed area 50x40 mm to L arm.  HPV and meningococcal vaccine administered in same arm.  Pain began same evening of vaccine administration.  Pt. took Aleve and hot shower, let hot water run on arm.
Hives/itchy rash and swelling at injection site, down left arm, left ankle/leg, right ankle/leg, and right upper arm; Hives/itchy rash and swelling at injection site, down left arm, left ankle/leg, right ankle/leg, and right upper arm; Hives/itchy rash and swelling at injection site, down left arm, left ankle/leg, right ankle/leg, and right upper arm; Hives/itchy rash and swelling at injection site, down left arm, left ankle/leg, right ankle/leg, and right upper arm; Hives/itchy rash and swelling at injection site, down left arm, left ankle/leg, right ankle/leg, and right upper arm; Nausea; Diarrhea; Weakness (difficultyclimbing stairs); This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol/norethisterone (ALYACEN) for an unknown indication from an unknown date and unknown if ongoing. On 03Apr2021, the patient experienced hives/itchy rash and swelling at injection site, down left arm, left ankle/leg, right ankle/leg, right upper arm, nausea and diarrhea lasting 6 days and weakness (difficulty climbing stairs). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event rash and included treatment with prednisone (MANUFACTURER UNKNOWN) and hydrocortisone (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent SARS CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events hives/itchy rash, swelling at injection site, down left arm, left ankle/leg, right ankle/leg, right upper arm, nausea diarrhea and weakness was resolved on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Over 12 hour period after vaccine administration, developed dizziness, severe headache, stiff neck, photophobia. Seen in ER that evening.
Dizziness, weakness, right-sided temple headache, episodic left abdominal pain, occasional feeling of shortness of breath.  All ongoing, no recovery yet.  No change with Antivert or Amoxil.  Now on Nasonex daily.
nauseous; fell; left side discomfort; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell), DISCOMFORT (left side discomfort) and NAUSEA (nauseous) in an 82-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced FALL (fell) and DISCOMFORT (left side discomfort). On 05-Apr-2021, the patient experienced NAUSEA (nauseous). At the time of the report, FALL (fell), DISCOMFORT (left side discomfort) and NAUSEA (nauseous) had resolved.            No concomitant medications were reported. Treatment includes ginger ale. patient said she will continue with her grapefruit juice and apple to help with the nausea.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: received on 20 May 2021. Outcome of Events updated from unknown to recovered.Patient would like to decline further FU
still not feeling well; pressure was high; Frustration/frustration and dissatisfaction; diagnosed on March 8th with covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her first shot on 01Mar2021, she was diagnosed on 08Mar2021 with covid. Her second shot was due on 21Mar2021, but she didn't take it because "she was still not feeling well. She rescheduled it for today at 6pm but her pressure was high", states "the hospital told her that once you get your first shot if you have covid you're supposed to get your next dose after 90 days and told her to call Pfizer". Caller vocalized frustration that she was being "talked around in circles" reporting that her doctor knows less than she does. The patient wanted to know what she should do about her second shot if she had covid after having my first dose. She also asked what is the timing that is recommended between the shots. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 72-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 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Reporter stated that no treatment was given to patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
pt c/o soreness, tenderness about 3 1/2 hrs lt deltoid area p/vax 19MAY94 vomited;
Two weeks after vaccine extreme episodes of near syncope and severe chest pain with paresthesia's down both arms, shortness of breath and tingling in brain and back. Since the vaccine I have the episodes regularly with severe headaches, brain fog, inability to function some days and complete loss of concentration. I have been seen multiple times over the last year in ER's for these symptoms.
Swollen lymph node in collar bone on the side of the injection site. Noticed 2 days after the shot