chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced LETHARGY (lethargic). On 07-Mar-2021 at 12:00 PM, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On 08-Mar-2021, LETHARGY (lethargic) had resolved. At the time of the report, BELL'S PALSY (Bell's Palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient began to experience paralysis of the facial muscles on the left side of his face along with lethargy that lasted one day. He was unable to blink his left eye and the left half of his tongue had no taste. He also reported blurry vision.  He subsequently called 911 and was diagnosed with Bell's Palsy in the emergency room that evening. That week, the left side of his face was drooping. He reported that it had tightened up and was more symmetrical now, however, he was still unable to smile, frown or blink from the left side of his face. He was scheduled to receive his second dose of the vaccine on 06-Apr-2021, however, his neurologist stated that she could not guarantee that it would not make his Bell's Palsy worse, but she still recommended getting the second dose. The medical staff at the base didn't know if he should get the second dose and his civilian doctor wouldn't commit. The emergency room physician contacted an Infectious Disease doctor who felt it would be fine for him to get the second dose.  Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient with apnea of prematurity on monitor had 2 mons. vaccines with subsequent apnea spell - cyanotic. Former 28 wk premie. Corrected gestation 36 wk.
Approximately 2 hr post receiving Typhoid vaccine in right deltoid pt. experienced "numbness" and "puffiness" distal to immunization site to wrist area.  Pt. states had pain at injection site at onset of immunization. Pt. denies any previous vaccine related reactions.
zoster keratitis; Zoster iridocyclitis of the left eye; Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a painful rash on the left side of his face, forehead and in his eye. He presented to his medical provider and was diagnosed with herpes zoster, zoster keratitis, and zoster iridocyclitis of the left eye. Despite receiving treatment, the patient continued suffering from herpes zoster, zoster Keratitis and zoster iridocyclitis of the left eye (not recovered). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events zoster Keratitis and zoster iridocyclitis of the left eye were determined to be medically significant. The events zoster Keratitis and zoster iridocyclitis of the left eye and herpes zoster were considered to be disabling.  Additional information has been requested.
product storage error; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication information provided. Individual vials or intact cartons: Intact cartons vial size was 5.5 ml.  Date the vial was initially stored in the refrigerator was 11-JAN-2023.  It was unknown if the vial had undergone any temperature excursions. No treatment information provided.
has Tinnitus real bad about a month after the covid Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (has Tinnitus real bad about a month after the covid Moderna shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced TINNITUS (has Tinnitus real bad about a month after the covid Moderna shot). At the time of the report, TINNITUS (has Tinnitus real bad about a month after the covid Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.
"squirted out" into the glove of the medical assistant when she was administering the dose; "squirted out" into the glove of the medical assistant when she was administering the dose; Nurse could not verify if the involved syringe was part of the V AQT A prefilled syringe formulation or if had been another syringe used after drawing up; no additional AE reported; This spontaneous report as received from a nurse referring to a female medical assistant of unknown age.  The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  It was reported that, while vaccinating a child with hepatitis a vaccine, inactivated (VAQTA), at least half' of the vaccine "squirted out" into the glove of the medical assistant when she was administering the dose. The medical assistant confirmed the needle was tightly on the syringe and that the vaccine did not leak out from the "needle point" but instead "squirted out from the syringe somehow (product quality issue, occupational exposure to product and accidental exposure to product).  Nurse could not verify if the involved syringe was part of the hepatitis a vaccine, inactivated (VAQTA) prefilled syringe formulation or if had been another syringe used after drawing up from the vial formulation. No adverse events were reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA008094:
At 1:30pm on Monday 5/31 I started to feel cramps in my pelvic area. I had gotten my period 2 days early, and was bleeding heavier than normal and had surprising diarrhea. I took 600mg of Advil and texted a friend at 2:10 that: "the womanly cramps are ripping up my insides and making me so sick." Still I though this was an incredibly painful but normal mensural cycle. By 2:45 when the Advil normally would have kicked in and made the cramping almost disappear, I had gotten much worse. I was spending the day with a friend who is an internal medicine doctor and so she monitored me closely. I had extreme chills and was very cold to the touch but was profosely sweating. I was unable to drink or eat anything due to the nausea. Sharp and constant pain radiated from my mid-pelvic area down to my knees and up to my chest. On a fairly consistent bases my legs contorted in involuntary cramping.    I felt like I was bleeding heavily (turns out I was not) and we attempted to go to the bathroom. I just the act of gently standing up I fainted and my friend caught me, gently returning me to the ground. When I became conscious she had my legs up and we went to the ER.
Patient received a vaccine on 04/06/2021 that was administered vaccine too high on the shoulder resulting in soreness and stiffness of the arm. Patient was seen in urgent care the morning of 04/08/2021 and received a Prednisone taper prescription. Doctor recommended range of mothing and stretching, possible physical therapy and to see an orthopedic doctor next week.
This spontaneous report was received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (dose,route and lot # not provided). The pharmacist stated that the patient had a negative or low titer for anti-HBs antibody following completion of the full hepatitis b vaccine (recombinant)(manufacturer unknown). The pharmacist did not know when the primary hepatitis b vaccine (recombinant)(manufacturer unknown) series was completed or when the negative or low titer result was reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Chills, low grade fever, severe body aches, head aches,  (for 2 days) injection site hematoma
Fatigue (unable to get out of bed  from 7AM to 7 PM),  Cold Sweats, low Grade Fever, Headache.
Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 7) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration date 09-Oct-2023). The NDC #, injection site, and route of administration were unknown. These two HEPLISAV-B Lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
No other AE; The patient inadvertently received a dose of VARlVAX on 9/14/2021.; a dose of VARlVAX on 7/30/2021./ The patient inadvertently received a dose of VARlVAX on 9/14/2021.; This spontaneous report was received from a pharmacist and refers to a 15-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 30-JUL-2021, the patient received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-SEP-2021, the patient came to the office and was scheduled to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). On that day the patient inadvertently received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No other adverse event was reported.
Facial swelling; Low grade fever around a 100; Got my eye supposedly my eye lids like little swelling and they looks like they are bruised and they itch like crazy; Got my eye supposedly my eye lids like little swelling and they looks like they are bruised and they itch like crazy; I have swelling in both of my eyes; It is getting pretty bad actually, it has got worse; This is a spontaneous report from a contactable nurse (reporting for herself).  A 41-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid vaccine by Pfizer, lot EJ1685), via an unspecified route of administration on 17Dec2020 at single dose for immunisation. Medical history included depression and anxiety. The patient's concomitant medications were not reported. The patient got the COVID vaccine on Thursday of last week (17Dec2020) and had low grade fever around a 100. On Friday (18Dec2020) she started getting little bit of facial swelling not a whole bunch. After the weekend, her eye lids had little swelling and they look like they were bruised and they itch like crazy. She does not have any drainage like conjunctivitis or anything like that but it looks like she have swelling in both of my eyes and that doesn't happens to her. She does not have any but was probably going in today because it was getting pretty bad actually, it has got worse. The outcome of events was not recovered.
Rashes; Chills; Tiredness; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes), CHILLS (Chills), FATIGUE (Tiredness) and MYALGIA (Muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced RASH (Rashes), CHILLS (Chills), FATIGUE (Tiredness) and MYALGIA (Muscle aches). At the time of the report, RASH (Rashes), CHILLS (Chills), FATIGUE (Tiredness) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact; Reporter's Comments: This case concerns a male of unknown age who experienced NS expected events of rash, fatigue, chills, and myalgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a pharmacist refers to a patient (age and gender unknown). On 04-FEB-2013, the patient was vaccinated with live (Merck) VARIVAX (lot #668542/0150AA; expiration date: 01-FEB-2013), 0.5 ml subcutaneous injection. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was inadvertently administered live (Merck) VARIVAX that had expired. No adverse effects reported. Additional information is not expected.
Blister type oral enanthema and reddish papular rash , fussiness 3 days post vaccination
I noticed a cluster of bright red splotches on my chest a few days after the 2nd covid shot.  The following day, the clump of red hives-like splotches were more intense. The third and fourth day, the cluster has broken up but there are tiny, paler red spots all across my chest and arms and legs.
Case number PHEH2013US023753 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 73-year-old male patient. He was vaccinated with expired vaccine of FLUVIRIN 2012/2013 (batch number 123303, expiry date: JUN 2013) at a dose of 0.5 ml intramuscularly on 18 OCT 2013. No adverse event was reported following this medication error (expired vaccine used).
Around 9 pm heart rate elevated. I wear a fitbit so I usually aware of my heart rate. When I laying down it was 100 it is normally 67.
I'm allergic to it; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a patient.   This case is linked to cases 2020SA353065 and 2020SA353066.  This case involves a patient of unknown demographics who was allergic to it (allergy to vaccine), while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route, administration site and expiry date unknown).   On an unknown date,  the patient was allergic to it (allergy to vaccine), (unknown latency) following the administration of influenza vaccine.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown at the time of reporting.  There will be no information available on the batch number for this case.
Urticaria rash on chest and arms. Pt given BENADRYL 250 mg PO x 1.
3 year old patient was given QUARDRACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case received on 05-Jan-2021 from a other health professional (Nurse) via call center through phone call.  This case involved a 3 year old patient who received an DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: unknown, expiry date: unknown) via unknown route and site on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  Nurse advised 3 year old patient was given QUARDRACEL, wants to know if dose is valid since it was before his 4th birthday".  The patient was due for DTap and IPV but they are only 3 years and 2 months of age and they received Quadracel. She would like to know if it is still valid. She said that it had been 6 months for their IPV and DTap dose and they will receive their booster after 4 years of age. This is all the information she was wiling to provide at the time of her call but she accepts follow up either in terms of a phone call or in writing.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Patient was seen 9/29/2021 for her 4 year well child exam. Past immunizations were reviewed and patient was administered scheduled 4 year shots of Proquad and Kinrix. Upon documentation it was then noted that patient received Proquad on 9/2/2020 at age 3.  1st dose of  MMR and Varicella were given at age 1, on 09/24/2018. Provider updated, family aware, no noted side effect at this time.
Patient called would not come in nor did she want to go to doctor. She described rash like blotches on arms and legs.
high pitched scream, clenching fists > 3 hrs; rx APAP;
Arm was a little sore whwn she left her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little sore whwn she left her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 VACCINATION SITE PAIN (Arm was a little sore whwn she left her arm). At the time of the report, VACCINATION SITE PAIN (Arm was a little sore whwn she left her arm) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Reporter stated that now her arm hurts but its not where she cant do anything. Its annoying and its little painful when she lifts her arm up and that also happened with second time. Caller also makes statement that her heart starts racing just thinking about what happened to her daughter with the covid vaccine.  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.
Unsure if related to Covid vaccination, however symptoms indicate an abrupt onset change for me so wanted them reported. After vaccination with Dose #2 of Pfizer Covid vaccine, had 1 menstrual cycle considered normal to my history.   Skipped the next cycle entirely without any spotting or symptoms typical of my period presentation (No chance of pregnancy). Currently experiencing the subsequent cycle and having symptoms very abnormal to my history.  Excessive and heavy bleeding, soaking through feminine products every 2-3 hours (currently in Day 3 of that symptom).  I have never experienced bleeding of this extreme in my lifetime.  OB/GYN aware, no treatment indicated at this time, follow up parameters have been provided by their office.
serve constant heart pain had to sleep siting up could not lean forward  two day to recover will be going to my primary doctor august 31 2022
Child in advertently received two doses of DTaP.  she is one of a set of twins who were to be immunized, each receiving a DTaP, IPV and MMR.  However, this child received 2 DTaP both in the right leg.
I received my 2nd booster shot on 04/03/2022 and my adverse event on 05/06/2022 Friday morning I was feeling dizzy, very tired, bad headache, sore throat, no fever. I did a home test on 05/07/2022 and tested positive. I spoke with my doctor through email she told me to quarantine for 10 days if anything unusual happens then to contact her again. She told me to test after 5 days and I tested positive on 05/12/2022 again. Then she told me to test again which will be 10 days all together. She recommended I should go to my clinic they provided me with a take home nasal swab and 2 COVID test. They told test on Friday and Saturday to test. If the test becomes positive on the 14th day they told me to contact my doctor. I still have fatigue, cough and headache and the dizziness.