chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine lot# 057A22A was administered on 30 Day after expiration date /The Dose was administered 1 day after date of expiry/ 1 patient affected).    No concomitant medications were reported. It was reported that it was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.
Vasovagal episode - on administration of VZV, Tdap and Polio immunizations had sudden feeling of lightheadedness and tensing of muscles.  Blood pressure was 83/41 automatic, 90/52 manual, pulse 60, Resps 20, O2 saturation 100% and blood sugar 92.
Vaccine recipient received the vaccine on 12/29/2020 and became nauseous. They reported that they developed pain and numbness at the injection site. The vaccine recipient was observed at the clinic and there were no other observed or reported symptoms. They reported that they had not eaten. They were given juice. The vaccine recipient was sent down to the ED and left on their own after feeling better without further medical intervention. Moderna COVID-19 Vaccine.
On 4/29, when I stood up to get out of bed, I immediately fell and hit my head on the floor. It was as if I blacked out for 2 seconds. I was able to sit up and stand up eventually and felt generally okay the rest of the day. On 4/30, I woke up with a lot of dizziness and was dizzy all day. Not vertigo, just off balance dizziness. Since then it has eased off gradually day by day.
I felt very lightheaded starting around 10 am Monday morning. Perhaps also some nausea but I did not vomit.  I had very slight pain at the injection site. I was not able to concentrate on my work for about 4 hours and felt unstable walking.  So I just rested.   I felt better later in the day, and was completely normal the next day.  I took more Aleve after I was already feeling better from the lightheaded feelings as I was continuing to experience cramping from my menstruation beginning early Monday (woke up a 4 am from pain and took Aleve then).  I have not experienced lightheaded feelings or inability to concentrate or unstable walking when I have had cramping or taken Aleve in the past.
Soreness at injection site; Following morning experienced headache and fatigue throughout day; Following morning experienced headache and fatigue throughout day; queasiness; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiry date: unknown) at 28 years of age via an unspecified route of administration on the right arm on 01Feb2021 at 09:15 am at a single dose for COVID-19 immunisation. Medical history and some surgeries were none. The patient has no allergies to medications, food, or other products. Concomitant medications included fluticasone propionate (50mcg) nasal spray and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took the first dose of BNT162B2 (lot number: EL3248, expiry date: unknown) on 12Jan2021 at 08:30 am on left arm for COVID-19 immunisation. The patient experienced soreness at injection site. Following morning experienced headache and fatigue throughout day. Some queasiness possibly related to vaccine. Following day, it was reported that the only remaining symptom is a slight headache. The events were assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events. The patient was recovering from the events.
Patient states that his arm at site of injeciton became enlarged, hard and red.  He states the reaction spread to all away around his arm and that it returned to normal within 24 hours.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
a. Minor "stinging" pain at injection site starting about 5 minutes after injection and lasting 2 to 3 minutes. b. 6 hours later general chill/low grade fever ~99.5 degrees F. lasting for about 4 hours.  c. Immediately after fever, nerve from lower back to right knee became very painful (more than ever before). This nerve had been giving me trouble for several years (spinal stenosis). A physical therapist alleviated the pain on 2/18 and 2/23, but the pain did not go away until 2/26. [This association of fever and reoccurrence or increased pain in areas where pain had receded has occurred in the past, usually associated with the flu. The same scenario occurred then; 4 to 8 hours of fever followed by sudden remission
5 days after vaccine got severe fatigue, headache, period of confusion and episode of tunnel vision. Sx's resolved after 2 days.
Received only the liquid portion with lyophilized powder.; Received only the liquid portion with lyophilized powder.; This case was reported by a physician via sales rep and described the occurrence of inappropriate reconstitution technique in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 13-Feb-2023. Reporter's Comment: Patient received only the liquid portion of Menveo booster dose without reconstitution with lyophilized powder. Reporter asked should the child be re dosed with a completely new dose. Reporter asked about the spacing be between the incorrect dose and the redoes and what should be done with the remaining powder vial of Men A. No other information provided (date of vaccination, lot number, expiration date, patients identifiers). The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: Patient received only the portion of Menveo without reconstitution, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered.
Rash & swollen eyes. Prednisone 30 mg daily x 3 day, Cetirizine 10 mg every day, Hydroxyzine 25 mg prn.
Received Tdap, MENACTRA and varicella vaccines. Mother states at site of varicella pt. c/o pain, burining immed. after shot. Then had swelling at site - was seen in ER - 8-3-13. Was told to take BENADRYL and it has hepled obut cont. to have swelling at site.
Patient reports itching for 4 days on his back beginning 11/3/18 received flu shot 11/1/18 tried BENADRYL for 1 day.
Patient had increased bruising / petechiae at about 1 week post vaccination.  Bloodwork was ran and patient had had a large drop in platelet count (down to 37,000).  Patient had low platelets previously but was at around 70,000 before vaccination)   Patient was prescribed Dexamethasone 40mg daily for 4 days. Following Dexamethasone Pt. reported A-fib (with Chest Pain and Heartburn Sx secondary to A-fib)  Platelet count has since increased and was last measured at 37,000 on or around 11/1/19
Additional dose of POLIO inadvertently administered at time of 2 mo. old immunization.
Mother called next day after immunization that daughter experiencing headache, arm numbness, tingle at site. No fever. Advised urgent care center but did not go.
Grandma states 2 days after immunizations, the right upper leg where shot was given the muscle separated from the bone; there was an indentation down the upper thigh. Took to doctor who stated it was OK just to keep eye on it. Took 2 months to heal per Grandma.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: pt immediately said she felt dizzy& eyes began to roll. Mom stated she has a fainting condition. Her Mom & I eased her to the ground. she briefly passed out, but immediately came to and asked what was happening. Her right leg was bent back but we lifted  her to straighten leg. I elevated her feet & got her some water. I also got her some gatorade & a cool wet paper towel for forehead. She leaned against her Mom for a little while, then she sat. Mom said not to call 911
Pt. awoke today with complains of left upper arm as painful, red & swollen. Went to school and vomited at 10:30 am, shivering, headache, nasal congestion and fever 101.8- presented to our office
Information has been received form a physician concerning a female who has tested positive for syphilis test several days after receiving the second dose of GARDASIL (therapy date, route, site unspecified). At the time of this report the patient was not recovered. The patient sought medical attention, she saw a physician. Additional information has been requested.
admitted for acute hypoxic respiratory failure and pneumonia due to COVID-19 virus,oxygen breathing treatment steroid antibiotic remdesivir. D/C to home in stable condition
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She was calling because she had the first dose of the Pfizer COVID vaccine on 28Dec2020. She developed a rash after one week and a half (in Jan2021). It was all over the body, extremely itchy and raised in certain areas of the body. Her body was unhappy, she had chills but no fever. She contacted her dermatologist and he suspected it was a reaction to the COVID- 19 vaccine. She had been taking meds as per dermatology since last Thursday (14Jan2021). The rash was fading but was still pretty obvious. She was a healthcare worker. She didn't notice any reaction for a couple of weeks. A week before or maybe a week and a half before (in Jan2021), she noticed dermatitis on her whole body. The dermatologist said she possibly had a reaction to the COVID vaccine. He told her to take Benadryl and Zyrtec. She saw him on Wednesday of last week and today (18Jan2021) was Monday. This rash was incredibly itchy. She thought it was fading a little bit. The second dose was due on the 20th, which was the day after tomorrow (20Jan2021). She read in the materials she was given that people who had serious reactions shouldn't get the second dose. Also she had had some muscle cramping in the stomach. She didn't have a follow up with the Dermatologist. She was assuming she should continue taking Zyrtec and Benadryl. Caller clarified that she got the generic, not the brand names. She took one Zyrtec a day that was 10mg. She took the Benadryl substitute and it was every 4 to 6 hours. If she had to drive in the afternoon she shouldn't take the Benadryl. She was wondering about the second dose. The outcome of the events a reaction to the COVID vaccine, rash/extremely itchy and raised in certain areas of the body was recovering, of the rest events was unknown. Information about lot/batch number has been requested.
Day 1:  Stage 1 - soreness / pain in left arm Day 2:  Stage 2 - soreness in left arm, flu-like symptoms of full body muscle and joint aching  and just not feeling well that peaked at 28 hours and lasted to 48  hours after injection.  Stage 1 - shivering at 30 hours after injection; lasted about an hour. I suffered with very severe Stage 3 side effects with the first dose vaccine; this 2nd dose vaccine was much less severe but nevertheless, it was a definite, clear reaction.
Patient reports waking up on 10/7/22(day after the vaccination) - with fever and body aches. Spent all night on the floor, could not get up and had no energy. Had to come to the Emergency Department.
About 3 weeks after vaccination started to notice facial tingling. Nose first then below left ear several days later. Ear area is now partially numb. Next day below right ear went partially numb. Next day left neck became partially numb. Also a worsening of a preexisting neuropathy on left back. No idea what will happen next. Trying to get a doctor appt, but no luck yet.
Patient hospitalized due to COVID-19 with weakness.  Low grade temp noted in the ER 99.9.  Infrequent loose cough noted, on room air, pulse ox is 94%.  Work-up in ED showed procalcitonin 0.19, BNP 8275, d-dimer 619. CRP 6.0, WBC 12.8, COVID-19 was positive. CXR with no pneumonitis. ECG with rate controlled afib. O2 sats at 94-96% on RA. CT head negative for ICH.
3/18/21 very sore arm, sore throat, horse, cough, headache, fever 101.4 high, chills, nausea, dizziness despite drinking 8-16 oz every 4 hrs throughout the night.   Symptoms continued through early morning, then felt better on 3/19/21 but still had HA, body aches, cough, sore thorat, no appetitie (nausea gone) and felt very wiped out.   Back to normal except arm still sore on 3/21/21.
swollen throat; little bit of facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swollen throat) and SWELLING FACE (little bit of facial swelling) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (swollen throat) and SWELLING FACE (little bit of facial swelling). At the time of the report, PHARYNGEAL SWELLING (swollen throat) and SWELLING FACE (little bit of facial swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Delayed 2 dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Delayed 2 dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Delayed 2 dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Delayed 2 dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received first shot but didn't go back for the second one like two weeks ago.  No relevant concomitant medications reported.  No treatment information was provided.
Profound neutropenia detected on Aug 6 2021 (200/uL). Followed with serial CBCs. Lowest was 150/uL on 8/12/21.  Cellcept was temporarily held. Neupogen was administered and ANC improved. Splenomegaly also worsened after the vaccine.
Following day arm sore spread to neck, shoulder frozen/legs numbness/heart arrhythmia feeling badly after 3 wks begin to feel better/shoulder still frozen.
Testing positive day 12; Testing positive day 12; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 at 01:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Chronic Bronchitis" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 02:00, outcome "not recovered" and all described as "Testing positive day 12". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that Paxlovid was taken as treatment for the events. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, patients were vaccinated with hepatitis B vaccine (manufacturer unknown) (dose, route, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, patients experienced injection site reaction: swelling, a raised knot and site was warm to the touch. No treatment was commenced. The events went away in 3 days. Patients sought unspecified medical attention. There was no lab diagnostic studies performed. The relatedness for injection site swelling, site was warm to the touch and raised knot is unknown for hepatitis B vaccine (manufacturer unknown). This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Client began to feel itchy, no hives or difficulty breathing noted. Offered Benadryl, pt stated she is allergic to Benadryl and can only take Allegra. Pt refused treatment offered and signed stating she was refusing it. Stated she would take Allegra when she got home. Client went home with family members.
Ascending paralysis with lesions found on MRI in the spinal cord. Suspicious of neuromyelitis optica. One month after completion of the MODERNA COVID-19 vaccine.
No adverse event reported by patient, expired vaccine was administered. Was transferred from Freezer to fridge on 4/1 however vial expired according to manufacturer expiration on 4/1/2022.
This spontaneous report as received from a licensed practical nurse refers to a 5 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with the dose of ROTATEQ (orally, lot # L013202; dose and expiration date were not reported) that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Addition information has been requested.
ILL; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced ill, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea and ill was not reported. This report was non-serious.
Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4 beginning at 8PM on 1/6/2021.  Vaccine given at 7:30 AM on 1/6/2021.  Still experiencing body aches as of 10am on 1/7/2021 but all other symptoms have improved.  No treatments given.
bladder always bothersome/lot pain with bladder; Pain; Urinary incontinence; left arm was really sore/Pain in arm; Musculoskeletal disorder/Bottom had started to bother; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER PAIN (bladder always bothersome/lot pain with bladder), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder/Bottom had started to bother), PAIN (Pain), URINARY INCONTINENCE (Urinary incontinence) and PAIN IN EXTREMITY (left arm was really sore/Pain in arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced MUSCULOSKELETAL DISORDER (Musculoskeletal disorder/Bottom had started to bother). On an unknown date, the patient experienced BLADDER PAIN (bladder always bothersome/lot pain with bladder), PAIN (Pain), URINARY INCONTINENCE (Urinary incontinence) and PAIN IN EXTREMITY (left arm was really sore/Pain in arm). At the time of the report, BLADDER PAIN (bladder always bothersome/lot pain with bladder), MUSCULOSKELETAL DISORDER (Musculoskeletal disorder/Bottom had started to bother), PAIN (Pain) and URINARY INCONTINENCE (Urinary incontinence) outcome was unknown and PAIN IN EXTREMITY (left arm was really sore/Pain in arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality was not reported for the event(s) of bladder always bothersome/lot pain with bladder and could not get off the toilet, bottom had started to bother, pain, left arm was really sore and bladder always bothersome/lot pain with the Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.