chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient missed the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.  The patient received first dose in Jan-2021 and was asking if it was too late to receive the second dose at the time of reporting.
Rash, wheezing (respiratory) 5 follow up visits as of 11/19/13 (albuterol) VENTOLIN and spirometry required.
I started sweating and aching plus there was a knot in my left arm where the vaccine was administered. I contacted my doctor and he said that it injured the tissue in my arm (caused the swelling). I had two weeks of fever and chills, not being able to walk, vomiting, and my arm was so swollen until I had to go to urgent care because I could not wear my shirts (looked like a bee sting reaction). I couldn't bend my arm and was not able to work during that time. I ended up going to the ER for my arm and the fever. The doctors said that I would eventually recover from the adverse event in time. It lasted for 8 days or 9 days (arm gradually went down approximately a week afterwards).
Pt vaccinated with Pneumovax 23/Influenza lt arm became weak due to brachial plexitis involving C-5.
Information has been received from a physician concerning a 8 week old patient, with no pertinent medical history, who on an unspecified date, was vaccinated with the first dose of ROTATEQ, orally.  Concomitantly, the patient also received other "normal" 2 month old vaccinations.  The physician reported that the patient experienced explosive, frequent and odorous diarrhea after receiving the vaccination.  At the time of the report, the patient had recovered.  Follow-up information has been received from the physician via telephone call indicating the patient's name, date of birth and vaccine's lot number (Lot # 661032/0469X).  The physician reported that the patient developed diarrhea one week after receiving the ROTATEQ.  The physician stated that the patient had recovered.  Additional information is not expected.
A week after receiving the Moderna shot in my left arm, the area around the injection site swelled up and became very hard and itchy. I also felt achy all over and very lethargic. It cleared up in a day, but I was told to report it.
Shots given 2/21/07 - mother reports adverse reaction on 4/10/07 - She states pt had rapid heart rate, fever, pale, dizziness, severe headache 2 hrs after injections x 48 hrs took 2 wks for child to return to normal - child did not start immunizations until age 7.
10 year old was erroneously given the Pfizer COMIRNATY vaccine which is for 12+ (instead of the Pfizer 5-11)
On June 21st in the evening I was sinus-y so I took a COVID test and it was negative. When I woke up the next morning, I had a scratchy throat and a fever of 99.2 so I took a TYLENOL. I took another antigen test and it was positive. I photographed them and sent them through my patient portal to my healthcare provider. I felt like I had hay fever. I requested PAXLOVID from my nurse practitioner. I started taking it on June 23, 2022. I have completed the 5 days regimen and have been testing negative since June 26, 2022. Symptoms were extremely mild. I have had colds that were worse that this. I am still sinus-y but that could be due to allergies.
First vaccine: Fever x 11 days post first vaccine. Had extensive work up which was unremarkable.   Second vaccine: currently on day 8 of fevers 100-102. No other symptoms.
This spontaneous report as received from a nurse refers to patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients received improperly stored (Merck) PROQUAD injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No other symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. Additional information has been requested.
Vaccine administered approx. 8:30 am. Client left room of administration and immediately felt. Had tingling and drawing of both hands, increase shallow respirations and pallor. 8:40 am pulse 123 resp 28  8:55 pulse 90 resp 23 b/p 100/60  9:10 am pulse 84 resp 20 B/P 100/62. Extreme stiffness of hands
Arm swelled up from point of shot down to elbow.Skin was hot where it was swelled,stiff, and achy.
Prior to administration I did speak to patient over what to generally expect  from the vaccine and ask her to stay in the store for 15 minutes after to watch for any adverse reactions and let her know they can happen but are not common.  She agreed to have the vaccine because she has been smoking and had a cough from  smoking ( no Covid symptoms) .Administered Pneumovax 23 in left deltoid at 10:35 am. Within one or two minutes as patient stood up she felt her throat was swelling and she began having difficulty breathing. She was gasping for air but able to talk. I asked tech to bring me the emergency kit. I had the EpiPen ready to administer but she was afraid for me to inject it. As we spoke about how the shot would work, her breathing improved. I took her blood pressure at 10:45am and it was 164/86 and pulse was 80. Her anxiety was also improving. At 10:49 am the ambulance paramedics arrived and I provided  patient details and history of incident. The paramedic listened to her chest and said he could hear some wheezing , recommending her to be seen by a doctor. She agreed to go to get checked out. They took about 10 min. to evaluate and then prepare patient for transport.
Injected me pretty high up on my shoulder that was a lot of pain; have a black and blue mark about a size of a quarter, up there the shot site; I didn't get a full does of second vaccine; felt bad; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient herself). A 72-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 04Mar2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 on 09Feb2021 (at the age of 72-year-old). Relevant medical history included low immunity. Concomitant medications were not reported. On an unknown date the patient experienced "injected me pretty high up on my shoulder that was a lot of pain then I felt a lot of cold fluid running down on my arm instead of getting in my body, was really cold like quite away after that wiped" (as reported), black and blue mark about a size of a quarter, up there the shot site, she didn't get a full does of second vaccine and felt bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Nausea; abdominal pain; rash purpura on lower legs; Leg sweling; low grade fever; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease and penicillin allergy. The patient had received other unspecified medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 11:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 the patient experienced severe headache. On 27Mar2021 the patient experienced low grade fever, purpuric rash on lower legs and leg swelling. On 28Mar2021 the patient experienced nausea and abdominal pain. On 29Mar2021, patient felt better and also the symptoms was resolved on 30Mar21. On 29Mar2021, the patient underwent lab tests which included covid virus test (nasal swab) and the result was negative. The adverse events did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. Therapeutic measures were taken as a result of the reported event was unknown. The clinical outcome of the events severe headache, low grade fever, purpuric rash on lower legs, leg swelling, nausea and abdominal pain were recovered on 30Mar2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a licensed practical nurse, referring to a 18 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 11-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # L004104 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Pain and swelling in all past injury locations. Ie. Neck pain with choking sensation.  6 days and counting Migraine, hearing difficulty, pain in arm with a rash, both thumb areas swelling and occasionally turn blue, right elbow pain, low back and abdominal pain, left knee pain and swelling (trouble walking) and finally the right ankle pain and swelling. All symptoms started within hours and gradually increased. The thumbs started turning colors on day 5. Pain and swelling continue except for the injection site and the accompanying rash gone on day 4. Nausea probably has to do with the migraine.
Pt vaccinated with DTP during night awakened with high pitched cry, temp of 102, leg was red at injection site. High pitched shrill cry, inconsolable lasted more than 3 hrs.
The pt felt dizzy, was observed for 20 minutes and returned to class. Approximately 1 hour post injection was brought back by adult. States she found the child coughing and vomiting in the restroom. The area of injection site is red, mottled, swollen and very warm to touch. Ice applied to injection site. Vitals are normal. The child states she did not eat dinner the night before and did not eat breakfast. Post vax, she ate some hot chili chips and began to cough. School physician notified parents and the child was sent home.
Patient was given a zoster vaccine on 11/21/11. He presented to his primary care physician on 11/30 with a shingles outbreak on his right lower extremity, which started two days after receiving the zoster vaccine. Patient also developed rash one day prior to his appointment. He was prescribed acyclovir and prednisone. Symptoms: Rash and shingles outbreak. Treatment: ACYCLOVIR 800 MG Other, PREDNISONE 5 MG Other.
Hypotension, nausea,  diaphoresis, vasovagal, syncope, left eye blurry vision , bradychardic, parathesia left side of face, resolved after an hour
Fuzzy. BP 132/104 (pulse 101), O2 sat 97%. Final BP 123/87 (pulse 93).
Initial unsolicited pregnancy report received from the literature on 16 November 2015. The following is verbatim from the article: OBJECTIVE: To determine whether receipt of Tdap vaccine during pregnancy administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverse events in mothers and adverse birth outcomes in neonates. EXPOSURES: Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before. MAIN OUTCOMES AND MEASURES: Acute adverse events (fever, allergy, and local reactions) and adverse birth outcomes (small for gestational age, preterm delivery, and low birth weight) were evaluated. Women who were vaccinated with Tdap in pregnancy and had a prior tetanus-containing vaccine more than 5 years before served as controls. RESULTS: There were no statistically significant differences in rates of medically attended acute adverse events or adverse birth outcomes related to timing since prior tetanus-containing vaccination. CONCLUSIONS AND RELEVANCE: Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before. These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy. This case involves a 29155 female patient who was vaccinated with a dose TDAP (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, 10 patients had developed fever, 15 patients had developed local reaction (cellulitis), 3 patients had allergic reaction/allergy, 8 patients had urticaria, 2 patients had local reaction (lymphadenitis), 8 patients had local reaction (limb swelling), 23 patients had local reaction (limb pain). There was a preterm delivery (unknown number of patients). It was a vaccine exposure during pregnancy. At the time of this report, 29084 patients had not experienced any adverse events. Relevant laboratory test results and corrective treatment was not reported. The outcomes of all the events were unknown. Documents held by sender: none.
p/vax pt devel a rash that consisted of greater than 50 vesicles on arms, face, & trunk;pt hosp & dx w/leukemia;tx w/chemotherapy;60 day follow-up received on 10/25/00 provided no additional data.
We contacted Seqirus with a question about whether or not the Flucelvax Quadravalent vaccine had a beyond use date.  We were counseled that it does, and that the vial should be discarded 28 days after the stopper has initially been pierced.  This information is not contained in the product information that accompanies the vaccine, nor in the online version.  I spoke with a supervisor who told me that this change was made 6 weeks ago, and that had I called before that date we would have been advised that it could be used through the expiration date on the vial.  She acknowledged that this advice was discordant from what is provided in the product information.  She stated there was no current guidance from the manufacturer as to whether a patient who had been administered the product after the BUD needed to have the dose repeated or if other risks to such patients were present.    I am seeking advice from the FDA/CDC as to how to address the change in manufacturing recommendation.  Specifically, should a patient who received the vaccine according to the FDA approved product information be contacted and offered a repeat dose?  If so, will the manufacturer bear the cost of this?  What type of notification will go out to health care providers and the general public regarding this change in product information?      1. The CDC indicates that some vaccines have a BUD from the manufacturer, and others do not.  When they do not, and the vial does not require reconstitution, the vaccine can be used through the expiration date printed on the label:      2. The CDC guidelines advise to use the package insert to know the manufacturer specification.       3. The CDC advises that any dose given outside the BUD window be repeated:
This spontaneous report was received from a pharmacist refers to a 19 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient's pertinent drug allergies/drug reactions were not reported. On an unknown date in June 2017 and august 207, the patient was vaccinated with first and second dose of GARDASIL 9 (dose, frequency, lot# and expiry date were unknown) route via intramuscular for an unknown indication at unknown locations. Patient was currently at the pharmacy to receive the third dose in the series today (26-NOV-2018) (inappropriate schedule of product administration) and no adverse effects have been reported in the patient (no adverse event).
Received COVID symptoms after receiving shots, had sore throat, turned out COVID positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Received COVID symptoms after receiving shots, had sore throat, turned out COVID positive) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 939905, 027A21A and 031l20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2023, the patient experienced COVID-19 (Received COVID symptoms after receiving shots, had sore throat, turned out COVID positive). At the time of the report, COVID-19 (Received COVID symptoms after receiving shots, had sore throat, turned out COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reportedly, patient had COVID symptoms after receiving shots, had sore throat. The COVID test turned out positive randomly. A week ago from the reporting day. patient had been quarantined.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2023: Live Significant Follow-Up information received: Vaccination details updated and patient information updated.
Approximately 15 minutes after Influenza, HepB, PCV13, DTaP-IPV/Hib and RV5 were administered, the patient's mother noticed that the patient's chest and right and left buttocks were covered in red, non-raised spots. Provider CNP was notified and evaluated the patient. CNP advised to monitor the spots for 15 more minutes. CNP reevaluated and then instructed the parents to look for anaphylactic signs and symptoms and seek immediate assistance if any of these signs and/or symptoms should appear. CNP recommended that the patient return in 4 weeks for the 2nd influenza vaccination, and that this appointment should coincide with a provider visit. Parents were in agreement with this plan.
Vaccine at 6:30pm on Thursday. Arm was very sore.  Woke up at 7am, tired, arm still very sore.  Took 2 tylenol, went to work, started to get a headache, on top of head, above my eyes. Took 2 more tylenol at about 1pm.  Starting to feel worse, finally left work at 3;30pm.  Went home, had fever about 100 or so.  As the evening went on, I had 102 fever, extreme pains, more so on my legs (especially my bad knee felt even worse), the worse headache I think that I ever had.  Even my breasts were sore.  it hurt just to lay down.  Took 2 more tylenol, felt the same.  Woke up the next morning, less pains, but my bad knee still hurted more than usual, 100 fever, tired, headache much less. Basically, had to lay down all day.  I had no energy.  Arm still very sore.  Sunday, felt much better, slightly more energy, arm still very sore.  Monday, feeling much better, but my arm is still very sore.
12 hours after second dose I started feeling very tired/ fatigue, chills and low fever. I stay in bed for over 24 hours feeling very weak. Fever went higher to 38.1C. I took 3 Tylenol to lower fewer during these 24hs.  I woak up on the hour 36 after event started feeling better (90% recovered) but notice a red rash on my chest. Look like some kind of reaction/allergy
My son had the shot and 3 hours later passed out on the bathroom floor. I called 911 and paramedics evaluated him, all vitals were normal and he felt ok 5 minutes later.
Injection site pain, body aches, headache, chills, fever to 100. Symptoms relieved with Aleve.
Patient stated pain at injection site and pain traveled down to the elbow for the next 3 days. It hurt to touch plus started to itch by the elbow around the 3rd day. Took TYLENOL on the 2nd and 3rd day. Still achy on the fourth but not enough to take anymore TYLENOL.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 08:30am. When error discovered facility contacted for course of action. At direction of the, patient contacted regarding occurrence to offer re-vaccination of dose. Patient declined revaccination. No adverse side effects or event as result of dose reported.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient was very nervous about receiving the vaccine. He had a panic attack afterwards, while being monitored closely in the store. He has had them in the past. He was fine once he calmed down, after 20 minutes or so.
Went to ED 8/16/07 - Pain and rash started 8/15/07 enlarging with increasing redness right thigh, 2 enlarged lymph nodes. Keflex 250mg/5ml give TID x 10 days.