chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Sick) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-737839, US-MODERNATX, INC.-MOD-2023-737836 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737839:For brother case (Same reporter) US-MODERNATX, INC.-MOD-2023-737836:2nd sister case
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Redness, swelling, hot to the touch and hard at the injection site the evening of the injections.  Complained that it was painful to walk on his left leg as well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pain in extremity
Clinical narrative: Redness, swelling, hot to the touch and hard at the injection site the evening of the injections.  Complained that it was painful to walk on his left leg as well.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Antiphospholipid antibodies, Chest pain, Erythema multiforme, Peripheral swelling, Pharyngeal swelling
Clinical narrative: Erythema Multiforme Rash, facial swelling, throat swelling, hand swelling, chest pain followed by daily urticaria.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Rheumatoid factor, Swelling face, Urticaria
Clinical narrative: Erythema Multiforme Rash, facial swelling, throat swelling, hand swelling, chest pain followed by daily urticaria.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Patient's mother states the patient started feeling numbness on the left side of his face on 8/22/23, with paralysis of the left side of his face beginning 8/23/23.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Axonal and demyelinating polyneuropathy, Dysstasia, Electromyogram abnormal, Hypoaesthesia, Mobility decreased
Clinical narrative: Weakness in the left leg, for example, making it difficult to go up and especially down stairs. Going down, I cannot let myself down gently. Hard to stand up from sitting position; can't squat. Intermittent numb feeling on inner aspect of right lower leg and top of foot. Symptoms developed subtly over past 6-9 months and I initially attributed the weakness to the known arthritis of the knees. Orthopedist said the weakness was not consistent with arthritis and would not improve with knee replacement.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: Weakness in the left leg, for example, making it difficult to go up and especially down stairs. Going down, I cannot let myself down gently. Hard to stand up from sitting position; can't squat. Intermittent numb feeling on inner aspect of right lower leg and top of foot. Symptoms developed subtly over past 6-9 months and I initially attributed the weakness to the known arthritis of the knees. Orthopedist said the weakness was not consistent with arthritis and would not improve with knee replacement.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Gave Vaccination past expiration date.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired when administered.
Age: 8.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: A single dose of a Menveo was left in box- unable to determine which of the 4 patients did not receive the entire dose (2 vials- powder and dilutant).  There has not been an adverse reaction to the vaccine- it is not knowing if the patient received the correct dose.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against and then tested positive for COVID19
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Single dose of multi vaccine found left in box.  We are unable to determine which patient did not get a full dose.  Patient did not have any adverse reaction but unsure if got full dose.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: Single vial of multidose vaccination remains in box of vaccines.  We were unable to determine which patient did not receive the full dose.  No adverse reaction from patient.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: A single dose of a multidose vaccination remained in box.  We are unsure which patient did not receive the total dose.  There was not adverse reaction to the vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: DOCTOR ORDERED DTAP/IPV VACCINE ON A 4-YEAR-OLD PATIENT. MEDICAL ASSITANT GAVE A PENTACEL INSTEAD OF A QUADRACEL. PARENT WAS CALLED AND MADE AWARE OF THE VACCINES GIVEN TO THE CHILD.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Dizziness, Gait disturbance, Headache, Nausea
Clinical narrative: I received a Flu vaccine and RSV but do not know which they were but was at same time/ It started with a head ache, then chills and i could not stop shaking, I think because i had a 101.2 fever. I became sick to my stomach and dizzy/unstable while walking.  trouble focusing vision. This is day two after shot and I still have head ache and low grade 101 fever.   Head ache id back of skull and low neck.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Neck pain, Pyrexia, Tremor, Vision blurred
Clinical narrative: I received a Flu vaccine and RSV but do not know which they were but was at same time/ It started with a head ache, then chills and i could not stop shaking, I think because i had a 101.2 fever. I became sick to my stomach and dizzy/unstable while walking.  trouble focusing vision. This is day two after shot and I still have head ache and low grade 101 fever.   Head ache id back of skull and low neck.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Hypoacusis
Clinical narrative: Approximately 3-5 mins after administration the patient stated he felt like he was going to pass out. He became dizzy, sweaty and stated  he couldn't hear as well as before getting the vaccine. Pt remained seated the entire time and never loss consciousness.  Vitals at 1835: 02=100%  BP=107/53  RR=18   HR=53   At approximately 1840 he stated feeling better and his symptoms resolved completely a few mins afterward.  Vitals at 1840:  02= 100%   BP=117/72   RR=20   HR=57.  Pt stood up slowly after last set of vitals were taken and left the vaccine site at approximately 1845 with no signs or symptoms of distress or complication from the reaction.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient reports that her right arm was sore and stiff the 1-2 days following the shot. More that when she gets flu shots, but not as bad as Shingrix shot, in her words. Then she began to notice more swelling, rash, and itching from shoulder blade, shoulder, arm down to right about elbow. She has not treated it, but at the time of reporting she said it was going down/getting better. Date she reported it was 8/24/23- 1 week after the vaccination. Pharmacist recommended contacting the Dr if the rash did not continue to get better or got worse again.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Injection site bruising, Urticaria
Clinical narrative: Employee called on 8/14/2023 to report bruising at injection site that began on 8/10/2023, temp of 102 began 8/11/2023.  Increased bruising and welting at the site noted on 8/14/2023.  Denies drainage.  Referred to PCP or Urgent Care
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Rash erythematous, Rash papular
Clinical narrative: On 7/16/23, 5-days after my second dose of Shingrix I experienced an itchy red, slightly raised rash with burning sensations on my right lower back (dermatomal pattern). I went to urgent care on 7/18/23, was diagnosed with shingles, and started on Valtrex. The rash was mild and resolved in about a week.   I had previously experienced shingles in Sept 2022 (right mid-back and abdomen), was also seen at urgent care, and treated with Valtrex. The episode of shingles in Sept was much more severe - quite painful with burning sensations, fatigue, pronounced vesicles, and the rash lasted several weeks.  I received my first dose of Shingrix on 2/7/23 (lot 429MK).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: On 7/16/23, 5-days after my second dose of Shingrix I experienced an itchy red, slightly raised rash with burning sensations on my right lower back (dermatomal pattern). I went to urgent care on 7/18/23, was diagnosed with shingles, and started on Valtrex. The rash was mild and resolved in about a week.   I had previously experienced shingles in Sept 2022 (right mid-back and abdomen), was also seen at urgent care, and treated with Valtrex. The episode of shingles in Sept was much more severe - quite painful with burning sensations, fatigue, pronounced vesicles, and the rash lasted several weeks.  I received my first dose of Shingrix on 2/7/23 (lot 429MK).
Age: 16.0
Sex: M
Vaccine: MENB, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient presented for well child exam. Patient was due for #2 Menveo and #1 Bexsero. Patient was given Bexsero and MMR instead of Menveo.  No adverse reactions noted.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse reactions reported.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Patient received DTap/ Hep B/ IPV vaccine and needed Hep B/ IPV/ Tdap.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse reactions reported.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient has not had any symptoms/ No additional AE/no PQC; a patient received an expired dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant referring to a 42 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml for prophylaxis (strength, route of administration, lot number and expiration date were not reported).   On 01-AUG-2023, the patient was vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (lot# U019139, expiration date reported as 30-JUN-2023, but upon internal validation established as 11-JUN-2023; strength, dose and route of administration were not reported) in left deltoid (LD) at private doctor's office/hospital (expired product administered). The patient had no side effects at the reporting time, and she was feeling okay.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Syringe issue
Clinical narrative: After administration of VAXNEUVANCE the prefilled syringe broke at the hub when the needle safety was applied.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Adverse event, Syringe issue
Clinical narrative: After administration of VAXNEUVANCE the prefilled syringe broke at the hub when the needle safety was applied.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTION NOTED.
Age: 65.0
Sex: F
Vaccine: PNC20, TD
Symptoms: Diarrhoea, Feeling cold, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea, muscle aches, vomiting, diarrhea, chilled,  supportive care
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Echocardiogram, Ejection fraction decreased, Implantable defibrillator insertion, Low cardiac output syndrome
Clinical narrative: few days after vaccine pt went into florid Congestive Heart failure and has low output cardiomyopathy since then with Ejection fraction = 25%.  Pt currently has AICD implanted
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Fatigue, Feeling abnormal, Hyperhidrosis, Pallor
Clinical narrative: After the 3 vaccines, patient started to faint, a pair of glasses dropped to the floor, weak, skin pale, sweating, checked BP 90/55 P50, patient stated he felt weird, after 3 minutes patient started to be back, verbalized " a little better" but " super tired". Patient gradually recovered after 15 minutes observation, rechecked BP 95/65, P 70.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: After the 3 vaccines, patient started to faint, a pair of glasses dropped to the floor, weak, skin pale, sweating, checked BP 90/55 P50, patient stated he felt weird, after 3 minutes patient started to be back, verbalized " a little better" but " super tired". Patient gradually recovered after 15 minutes observation, rechecked BP 95/65, P 70.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthma, Condition aggravated, Hypoxia
Clinical narrative: ACUTE RESPIRATORY FAILURE 5/1/2023 ALLERGIC ASTHMA, UNSPECIFIED, W ACUTE EXACERBATION ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/1/2023 ALLERGIC ASTHMA, UNSPECIFIED, W ACUTE EXACERBATION HYPOXIA 4/30/2023 ALLERGIC ASTHMA, UNSPECIFIED, W ACUTE EXACERBATION
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Benign prostatic hyperplasia, Chronic kidney disease, Deep vein thrombosis, Diabetic nephropathy, Glomerular filtration rate
Clinical narrative: ACUTE DVT OF LEFT FEMORAL VEIN 4/23/2023 DM 2 W CKD STAGE 3A (GFR 45-59) HYPOTENSION 5/3/2023 DM 2 W CKD STAGE 3A (GFR 45-59) ACUTE DVT OF LEFT FEMORAL VEIN 4/23/2023 BPH W URINARY RETENTION HYPOTENSION 5/3/2023 BPH W URINARY RETENTION
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Urinary retention
Clinical narrative: ACUTE DVT OF LEFT FEMORAL VEIN 4/23/2023 DM 2 W CKD STAGE 3A (GFR 45-59) HYPOTENSION 5/3/2023 DM 2 W CKD STAGE 3A (GFR 45-59) ACUTE DVT OF LEFT FEMORAL VEIN 4/23/2023 BPH W URINARY RETENTION HYPOTENSION 5/3/2023 BPH W URINARY RETENTION
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Viral rash
Clinical narrative: Afternoon after receiving the vaccine she reported redness in the arm and viral like rash on sides of trunk, more on the left side then the right side.  Did not itch and NO swelling in the area or mouth or tongue.  The redness faded by 6/11/2023.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Benign prostatic hyperplasia, Urinary retention
Clinical narrative: BPH W URINARY RETENTION
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Brain fog, Computerised tomogram, Electrocardiogram, Fall, Haemorrhage
Clinical narrative: He got his vaccine and the initial reaction on the first day and the beginning of the 2nd day was soreness in the area of the vaccine.  About 9:00 AM the following morning he started feeling funny in his head.  He was going to meet one of his son's at noon and he drove to where they were going to meet, and was in the parking lot where they were meeting, and about 11:15 his condition in his head got worse, and his son called him about 10 to noon and he told him he was almost there.  He got out of his car, locked it up and leaned against the car and his head condition got worse and worse and he drove into the parking lot, but he was not aware of it, out of it, but still standing. Before his son got to him his son saw him fell over, he passed out he says.  He fell on the parking lot asphalt and hit the side of his head on the parking lot stoppers.  He struck his head and has a bump on the head on the left rear quadrant, and his fingers on his right hand are all skinned up, elbows skinned up, his knee on the left, and the palm of his hand on the right is skinned up as well.  The first thing he recalls after passing out was his son leaning over him with his cell phone in his hand calling 911, and paramedics came and got him and he went to the ER.  He went to Medical Center.  He was still messed up in the head when he arrived there, his son explained to the paramedics what happened, and he does not know what the paramedics told the hospital staff.  He was injured and bleeding.  He had x-rays, a CT scan, EKG.  He has a heart issue and has two cardiologist and an electrophysiology physician.  After the EKG they thought that he was having a heart attack or something.  They acted like it was heart related, and he told them that he had the flu vaccine, which they ignored that.    After 2 hours they cleaned up his wounds, and bandage them.  His hands had bled, and all his other areas were dressed.  They wanted to keep him at the hospital and check out his heart well, he told them that he has 2 cardiologist and they did not need to check him for that.    He had experienced the same reaction when he had the Azithromycin in June.  He thought he was dying with that and called 911 himself.  They checked his BP was 212/197 and was taken to the hospital.  He was given Carvedilol and wanted him to stay in the hospital, and was released as he refused to stay.  Discharge BP 199/119. later it was 138/82.    He went home later that afternoon, and for the next 13 days he stayed at home dressing his wounds and recovering.  He feels pretty good now, but is not completely over the consequences of the fall, and his head is still not really clear and back to normal.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Head injury, Injection site pain, Loss of consciousness, Skin abrasion, X-ray
Clinical narrative: He got his vaccine and the initial reaction on the first day and the beginning of the 2nd day was soreness in the area of the vaccine.  About 9:00 AM the following morning he started feeling funny in his head.  He was going to meet one of his son's at noon and he drove to where they were going to meet, and was in the parking lot where they were meeting, and about 11:15 his condition in his head got worse, and his son called him about 10 to noon and he told him he was almost there.  He got out of his car, locked it up and leaned against the car and his head condition got worse and worse and he drove into the parking lot, but he was not aware of it, out of it, but still standing. Before his son got to him his son saw him fell over, he passed out he says.  He fell on the parking lot asphalt and hit the side of his head on the parking lot stoppers.  He struck his head and has a bump on the head on the left rear quadrant, and his fingers on his right hand are all skinned up, elbows skinned up, his knee on the left, and the palm of his hand on the right is skinned up as well.  The first thing he recalls after passing out was his son leaning over him with his cell phone in his hand calling 911, and paramedics came and got him and he went to the ER.  He went to Medical Center.  He was still messed up in the head when he arrived there, his son explained to the paramedics what happened, and he does not know what the paramedics told the hospital staff.  He was injured and bleeding.  He had x-rays, a CT scan, EKG.  He has a heart issue and has two cardiologist and an electrophysiology physician.  After the EKG they thought that he was having a heart attack or something.  They acted like it was heart related, and he told them that he had the flu vaccine, which they ignored that.    After 2 hours they cleaned up his wounds, and bandage them.  His hands had bled, and all his other areas were dressed.  They wanted to keep him at the hospital and check out his heart well, he told them that he has 2 cardiologist and they did not need to check him for that.    He had experienced the same reaction when he had the Azithromycin in June.  He thought he was dying with that and called 911 himself.  They checked his BP was 212/197 and was taken to the hospital.  He was given Carvedilol and wanted him to stay in the hospital, and was released as he refused to stay.  Discharge BP 199/119. later it was 138/82.    He went home later that afternoon, and for the next 13 days he stayed at home dressing his wounds and recovering.  He feels pretty good now, but is not completely over the consequences of the fall, and his head is still not really clear and back to normal.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Diffuse rash
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 14.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Abdominal pain lower, Defaecation urgency, Eye movement disorder, Feeling abnormal, Hyperhidrosis
Clinical narrative: Patient started to faint right away after Tdap and HepB vaccine given, both eyes roll up for 10 seconds, muscle stiffening and loss of consciousness for 20 seconds, skin pale, sweating, patient returned consciousness and asked, "what happened? feeling weird".  Three minutes later patient started to have low abdominal pain and had a feeling of bowel movement. Then patient went to bathroom with assistant had a huge bowel movement. Patient returned to exam room and lay down to exam bed, still have skin pale and sweating.  After 15 minutes observation of patient lying down on exam bed, she recovered.
Age: 14.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Patient started to faint right away after Tdap and HepB vaccine given, both eyes roll up for 10 seconds, muscle stiffening and loss of consciousness for 20 seconds, skin pale, sweating, patient returned consciousness and asked, "what happened? feeling weird".  Three minutes later patient started to have low abdominal pain and had a feeling of bowel movement. Then patient went to bathroom with assistant had a huge bowel movement. Patient returned to exam room and lay down to exam bed, still have skin pale and sweating.  After 15 minutes observation of patient lying down on exam bed, she recovered.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient was administered a booster dose of Moderna Bivalent vaccine on 8/16/23, however upon a clinic inspection on 8/23/23 it was noticed that the probe wire had been severed and was showing improper read outs.    Upon review that last temp recorded in the correct range had been on 7/26/23 at 1003am.  #1 issue did not alarm as it should have.    After contacting Moderna on 8/23/23 stating that the temp of the vaccine was truly unknown from 7/26/23-8/23/23 and there could have been deviation for >24 hours the stock was deemed unusable and discarded.  When running a report only 1 patient had received the vaccine on 8/16/23.  The patient was contacted and told that guidelines, due to the temp excursion, no harm had come to him however there will be no efficacy of the vaccine and he will need to get a repeat dose as soon as he is able.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Injection site warmth, Rash papular
Clinical narrative: Patient called our office on 8/23/23 stating she had a raised hot rash at the site where the prevnar shot was given. NP  advised patient to use cold compress on the site and use antihistamine prn. I called patient on 8/24/23 to follow up with her and she stated after doing the recommendations it has almost completely resolved.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse event; Nurse called to report a 26-year-old patient who received 3 doses of VARIVAX; the third dose being administered in the buttocks; This spontaneous report was received from a nurse refers to a 26-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2002, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On 05-JUL-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On 02-AUG-2023, the patient was vaccinated with the third dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, exact dose, route of administration were not reported), anatomical location was reported as in the buttocks for prophylaxis (extra dose administered, product administered at inappropriate site). No additional adverse event (no adverse event).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: headache, too achy all over for good sleep, fatigue
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Fall, Pallor, Syncope
Clinical narrative: Patient fainted after receiving  vaccines and fell to the ground. Patient appeared pale and faint. Patient was given crackers, juice, and vitals were monitored. Parents were given information on when to return to clinic or seek care. Patient was up and talking upon leaving.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Skin warm, Urticaria
Clinical narrative: She got her vaccine, the first day not really anything, she did not really feel the shot itself.  The next morning she had a little soreness when she stretched her, and forgot that she had gotten it, a little pang once in a while which she did not relate to the vaccine.  Then around Saturday she noticed redness, which has gotten broader and broader on her arm, and has whelted from her shoulder down to her elbow.  It is red on the top, goes over to the side, feels a little warm, and a little tight.  She took Tylenol at first for the first couple of days, put ice on it.  She went to pharmacy yesterday and showed it to them, did not seem concerned.  She called the RN hotline at insurance, which she told her to take Ibuprofen, and did help with some of othe achiness until it wore off.  It seems to have spread further this morning, going down to the side of her front and back side of the arm.  It seems like each day it is getting worse instead of better.  She called the 24-hour nurse line, and was told that it could be celluitis, an infection and was told that she needed to get it looked out as it may get into her blood stream, or be an infection.  She has an appointment with her doctor today at 1:30.    She only got some sorness on her arm from other vaccines, but nothing like this.
Age: 1.92
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: 1 week later onset of papular rash on the face which then spread to remainder of body which was pruritic
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Decreased appetite
Clinical narrative: June 27th: patient reported feeling "slightly light-headed" in the evening. Patient denied any S/S immediately and 15 minutes after vaccination.   June 28th: Patient reported that she started experiencing general malaise, chills, fever (although patient stated "I never actually took my temperature"), night sweats, and dramatic increase in thirst. Patient stated "the weakness was so bad I could barely walk or hold onto a glass of water". Patient also reported frequent glucose cravings.   Patient stated that symptoms lasted several days. she woke up several nights "drenched in sweat" and "could barely get out of bed".   Patient stated that after the 1st week of symptoms, she called her PCP. Patient stated that she spoke to the triage nurse. Patient stated that the triage nurse stated "sounds like you just need to ride this out" and encouraged lots of fluids and rest.  Patient stated that over the course of 3 to 4 weeks, other symptoms she experienced included: join ache, blotchy chest, red blotches on the legs, general aching, malaise, decreased appetite, upper shoulder pains that were not long in duration, and bladder incontinence. Patient denies ever having pain at the injection site but stated the right arm felt "sensitive".   Patient reported that at the end of July symptoms have improved but she is still experiencing back aches, hot spots under the arms, itching, fatigue, weakness, and hand tremors.   Patient stated that she started taking astragalus after symptoms.   Patient called to report adverse event on 8/22/2023. Patient denied ever seeking medical attention with the exception of contacting PCP 1 week following the start of symptoms. Patient stated that she has an appointment to see a medical provider on 8/23/2023.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Feeling hot, Food craving, Gait disturbance
Clinical narrative: June 27th: patient reported feeling "slightly light-headed" in the evening. Patient denied any S/S immediately and 15 minutes after vaccination.   June 28th: Patient reported that she started experiencing general malaise, chills, fever (although patient stated "I never actually took my temperature"), night sweats, and dramatic increase in thirst. Patient stated "the weakness was so bad I could barely walk or hold onto a glass of water". Patient also reported frequent glucose cravings.   Patient stated that symptoms lasted several days. she woke up several nights "drenched in sweat" and "could barely get out of bed".   Patient stated that after the 1st week of symptoms, she called her PCP. Patient stated that she spoke to the triage nurse. Patient stated that the triage nurse stated "sounds like you just need to ride this out" and encouraged lots of fluids and rest.  Patient stated that over the course of 3 to 4 weeks, other symptoms she experienced included: join ache, blotchy chest, red blotches on the legs, general aching, malaise, decreased appetite, upper shoulder pains that were not long in duration, and bladder incontinence. Patient denies ever having pain at the injection site but stated the right arm felt "sensitive".   Patient reported that at the end of July symptoms have improved but she is still experiencing back aches, hot spots under the arms, itching, fatigue, weakness, and hand tremors.   Patient stated that she started taking astragalus after symptoms.   Patient called to report adverse event on 8/22/2023. Patient denied ever seeking medical attention with the exception of contacting PCP 1 week following the start of symptoms. Patient stated that she has an appointment to see a medical provider on 8/23/2023.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Grip strength decreased, Hyperhidrosis, Hypersensitivity, Malaise, Middle insomnia
Clinical narrative: June 27th: patient reported feeling "slightly light-headed" in the evening. Patient denied any S/S immediately and 15 minutes after vaccination.   June 28th: Patient reported that she started experiencing general malaise, chills, fever (although patient stated "I never actually took my temperature"), night sweats, and dramatic increase in thirst. Patient stated "the weakness was so bad I could barely walk or hold onto a glass of water". Patient also reported frequent glucose cravings.   Patient stated that symptoms lasted several days. she woke up several nights "drenched in sweat" and "could barely get out of bed".   Patient stated that after the 1st week of symptoms, she called her PCP. Patient stated that she spoke to the triage nurse. Patient stated that the triage nurse stated "sounds like you just need to ride this out" and encouraged lots of fluids and rest.  Patient stated that over the course of 3 to 4 weeks, other symptoms she experienced included: join ache, blotchy chest, red blotches on the legs, general aching, malaise, decreased appetite, upper shoulder pains that were not long in duration, and bladder incontinence. Patient denies ever having pain at the injection site but stated the right arm felt "sensitive".   Patient reported that at the end of July symptoms have improved but she is still experiencing back aches, hot spots under the arms, itching, fatigue, weakness, and hand tremors.   Patient stated that she started taking astragalus after symptoms.   Patient called to report adverse event on 8/22/2023. Patient denied ever seeking medical attention with the exception of contacting PCP 1 week following the start of symptoms. Patient stated that she has an appointment to see a medical provider on 8/23/2023.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Night sweats, Pain, Pyrexia, Rash
Clinical narrative: June 27th: patient reported feeling "slightly light-headed" in the evening. Patient denied any S/S immediately and 15 minutes after vaccination.   June 28th: Patient reported that she started experiencing general malaise, chills, fever (although patient stated "I never actually took my temperature"), night sweats, and dramatic increase in thirst. Patient stated "the weakness was so bad I could barely walk or hold onto a glass of water". Patient also reported frequent glucose cravings.   Patient stated that symptoms lasted several days. she woke up several nights "drenched in sweat" and "could barely get out of bed".   Patient stated that after the 1st week of symptoms, she called her PCP. Patient stated that she spoke to the triage nurse. Patient stated that the triage nurse stated "sounds like you just need to ride this out" and encouraged lots of fluids and rest.  Patient stated that over the course of 3 to 4 weeks, other symptoms she experienced included: join ache, blotchy chest, red blotches on the legs, general aching, malaise, decreased appetite, upper shoulder pains that were not long in duration, and bladder incontinence. Patient denies ever having pain at the injection site but stated the right arm felt "sensitive".   Patient reported that at the end of July symptoms have improved but she is still experiencing back aches, hot spots under the arms, itching, fatigue, weakness, and hand tremors.   Patient stated that she started taking astragalus after symptoms.   Patient called to report adverse event on 8/22/2023. Patient denied ever seeking medical attention with the exception of contacting PCP 1 week following the start of symptoms. Patient stated that she has an appointment to see a medical provider on 8/23/2023.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Rash macular, Thirst, Tremor, Urinary incontinence
Clinical narrative: June 27th: patient reported feeling "slightly light-headed" in the evening. Patient denied any S/S immediately and 15 minutes after vaccination.   June 28th: Patient reported that she started experiencing general malaise, chills, fever (although patient stated "I never actually took my temperature"), night sweats, and dramatic increase in thirst. Patient stated "the weakness was so bad I could barely walk or hold onto a glass of water". Patient also reported frequent glucose cravings.   Patient stated that symptoms lasted several days. she woke up several nights "drenched in sweat" and "could barely get out of bed".   Patient stated that after the 1st week of symptoms, she called her PCP. Patient stated that she spoke to the triage nurse. Patient stated that the triage nurse stated "sounds like you just need to ride this out" and encouraged lots of fluids and rest.  Patient stated that over the course of 3 to 4 weeks, other symptoms she experienced included: join ache, blotchy chest, red blotches on the legs, general aching, malaise, decreased appetite, upper shoulder pains that were not long in duration, and bladder incontinence. Patient denies ever having pain at the injection site but stated the right arm felt "sensitive".   Patient reported that at the end of July symptoms have improved but she is still experiencing back aches, hot spots under the arms, itching, fatigue, weakness, and hand tremors.   Patient stated that she started taking astragalus after symptoms.   Patient called to report adverse event on 8/22/2023. Patient denied ever seeking medical attention with the exception of contacting PCP 1 week following the start of symptoms. Patient stated that she has an appointment to see a medical provider on 8/23/2023.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 1.92
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient was given siblings vaccines. Patient did not need MMRV, HIB or Pneumo.  Vaccinations were going to be given to sibling and patient was put on the exam table.  Explained to pt. per supervisor she has had these imms. already and should not harm her had patient wait 20 mins.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN ARM FOR ABOUT TWO WEEKS
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red and swollen area of skin at injection site, approximately 10cm in size, hot to the touch, painful and itchy. Low grade fever 100.4 F
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: patient was dizzy.  She had not eaten all morning.  we gave her coke and crackers and she was doing fine before she left.
Age: 12.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient had an order to received MCV4 and instead received MenB
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Shoulder pain starting 1-2 days after administration and persisting now 6 days,  limited range of movement
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic arteriosclerosis, Coagulopathy, Pulmonary mass
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE 3/7/2023 SOLITARY PULMONARY NODULE COAGULOPATHY, UNSPECIFIED TYPE 3/7/2023 ATHEROSCLEROSIS OF AORTA
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Facial paresis
Clinical narrative: LEFT FACIAL MUSCLE WEAKNESS 4/18/2023 WEAKNESS
Age: 11.0
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous report has been received from a lawyer, via immunization record from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS # 2303USA000135), concerning a 11-year-old male patient (pt). Concomitant vaccines included hepatitis a vaccine (+) inactivated (VAQTA), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA). Information about concurrent condition and medical history was not reported.   On 01-APR-2014, the pt was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally for prophylaxis (strength, dose, lot #, and expiry date were not provided) (product administered to patient of inappropriate age).  This is one of several reports for the same pt.; Sender's Comments:  US-009507513-2303USA000135:
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebellar artery occlusion, Cerebrovascular accident, Dizziness
Clinical narrative: I63.89 SUPERIOR CEREBELLAR ARTERY SYNDROME 4/13/2023 DIZZINESS I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/29/2023 DIZZINESS
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Eye movement disorder, Immediate post-injection reaction, Myoclonus, Pallor, Posture abnormal
Clinical narrative: Immediately following the last vaccine (HPV) child became pale, her eyes rolled up and she slumped down in the chair and had  myoclonic jerks.  She was laid flat and her legs were elevated.  She never had complete loss of consciousness.  She was oriented throughout.   After 5-10 mins the pallor in her face resolved and she was able to sit up.  She was discharged in the care of her mother.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cor pulmonale acute, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM 4/3/2023 SADDLE PULMONARY EMBOLISM W ACUTE COR PULMONALE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/2/2023 SADDLE PULMONARY EMBOLISM W ACUTE COR PULMONALE ACUTE DVT OF LEFT FEMORAL VEIN 4/2/2023 SADDLE PULMONARY EMBOLISM W ACUTE COR PULMONALE
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Hypotension
Clinical narrative: HYPOTENSION 4/26/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma-chronic obstructive pulmonary disease overlap syndrome, Cerebrovascular accident
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/7/2023 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood test normal, Chills, Ear swelling, Erythema
Clinical narrative: 8/6 in the evening. Severe joint pain, headache, body aches. Both sides of my body. 8/7 in the morning no noticeable symptoms. In the evening: joint pain, chills, headache, occipital pain (painful to the touch), parathesia, neck pain/swelling. Fever which increased over the course of the evening to over 100 degrees. Pain was bilateral. 8/8 Symptoms continued, swollen lymph nodes in neck. Fever increased to 103 degrees (oral temperature). 8/9 Fever & aches resolved in the morning. Joint pain and fever returned in the afternoon. New face pain along cheeks along with swelling and a rash. 8/10 Temperature was lower, but still above normal. Facial pain worsened over the course of the day and temperature reached 100 degrees. 8/11 Facial pain continued, temperature increased in evening. 8/12 Slightly elevated temperature (98.7 vs normal 97.7); face very red and itchy; left ear also red, swollen and hot to touch. 8/13: Headache in a.m.; mostly normal temp; face still has swelling in new locations - mostly on the left side, bridge of nose & eyebrows painful to the touch; facial redness/rash much diminished, but still some patches. 8/14: No headache in a.m., normal temp; left cheek still swollen, nose swollen & red, and swelling around tear ducts. 8/18 Temperature back to normal all day. Left side of face still slightly swollen, but no pain.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial pain, Headache, Lymphadenopathy, Neck pain, Pain
Clinical narrative: 8/6 in the evening. Severe joint pain, headache, body aches. Both sides of my body. 8/7 in the morning no noticeable symptoms. In the evening: joint pain, chills, headache, occipital pain (painful to the touch), parathesia, neck pain/swelling. Fever which increased over the course of the evening to over 100 degrees. Pain was bilateral. 8/8 Symptoms continued, swollen lymph nodes in neck. Fever increased to 103 degrees (oral temperature). 8/9 Fever & aches resolved in the morning. Joint pain and fever returned in the afternoon. New face pain along cheeks along with swelling and a rash. 8/10 Temperature was lower, but still above normal. Facial pain worsened over the course of the day and temperature reached 100 degrees. 8/11 Facial pain continued, temperature increased in evening. 8/12 Slightly elevated temperature (98.7 vs normal 97.7); face very red and itchy; left ear also red, swollen and hot to touch. 8/13: Headache in a.m.; mostly normal temp; face still has swelling in new locations - mostly on the left side, bridge of nose & eyebrows painful to the touch; facial redness/rash much diminished, but still some patches. 8/14: No headache in a.m., normal temp; left cheek still swollen, nose swollen & red, and swelling around tear ducts. 8/18 Temperature back to normal all day. Left side of face still slightly swollen, but no pain.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Pruritus, Pyrexia, Rash, Skin warm
Clinical narrative: 8/6 in the evening. Severe joint pain, headache, body aches. Both sides of my body. 8/7 in the morning no noticeable symptoms. In the evening: joint pain, chills, headache, occipital pain (painful to the touch), parathesia, neck pain/swelling. Fever which increased over the course of the evening to over 100 degrees. Pain was bilateral. 8/8 Symptoms continued, swollen lymph nodes in neck. Fever increased to 103 degrees (oral temperature). 8/9 Fever & aches resolved in the morning. Joint pain and fever returned in the afternoon. New face pain along cheeks along with swelling and a rash. 8/10 Temperature was lower, but still above normal. Facial pain worsened over the course of the day and temperature reached 100 degrees. 8/11 Facial pain continued, temperature increased in evening. 8/12 Slightly elevated temperature (98.7 vs normal 97.7); face very red and itchy; left ear also red, swollen and hot to touch. 8/13: Headache in a.m.; mostly normal temp; face still has swelling in new locations - mostly on the left side, bridge of nose & eyebrows painful to the touch; facial redness/rash much diminished, but still some patches. 8/14: No headache in a.m., normal temp; left cheek still swollen, nose swollen & red, and swelling around tear ducts. 8/18 Temperature back to normal all day. Left side of face still slightly swollen, but no pain.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling, Swelling face, Tenderness
Clinical narrative: 8/6 in the evening. Severe joint pain, headache, body aches. Both sides of my body. 8/7 in the morning no noticeable symptoms. In the evening: joint pain, chills, headache, occipital pain (painful to the touch), parathesia, neck pain/swelling. Fever which increased over the course of the evening to over 100 degrees. Pain was bilateral. 8/8 Symptoms continued, swollen lymph nodes in neck. Fever increased to 103 degrees (oral temperature). 8/9 Fever & aches resolved in the morning. Joint pain and fever returned in the afternoon. New face pain along cheeks along with swelling and a rash. 8/10 Temperature was lower, but still above normal. Facial pain worsened over the course of the day and temperature reached 100 degrees. 8/11 Facial pain continued, temperature increased in evening. 8/12 Slightly elevated temperature (98.7 vs normal 97.7); face very red and itchy; left ear also red, swollen and hot to touch. 8/13: Headache in a.m.; mostly normal temp; face still has swelling in new locations - mostly on the left side, bridge of nose & eyebrows painful to the touch; facial redness/rash much diminished, but still some patches. 8/14: No headache in a.m., normal temp; left cheek still swollen, nose swollen & red, and swelling around tear ducts. 8/18 Temperature back to normal all day. Left side of face still slightly swollen, but no pain.