chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 66 year elderly female. Initial information was processed along with additional on 17-MAY-2022. The patient's height, and weight were not reported. The patient's past medical history included: headaches and abnormal EEG (electroencephalogram), and concurrent conditions included: hypothyroidism, lichen sclerosis, drug allergy (Clindamycin, ampicillin and cephalosporins) and food allergy (raw onions), and other pre-existing medical conditions included: The patient was a heath care professional (nurse). The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: unknown) dose was not reported, 1 total administered on 30-MAR-2021 for prophylactic vaccination. Age at time of vaccination 65 years old. Concomitant medications included benzonatate, estradiol, levothyroxine sodium, prednisone, and salbutamol. On 08-MAY-2022 patient had vaccination failure (dose number in series 1). The patient received additional dose of Spikevax (Moderna) (elasomeran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 939903 and expiry: unknown) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination.  On 30-APR-2022, patient received Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: FR7229 and expiry: unknown) dose not reported for treatment of COVID-19. The patient completed the course of 5 days of Paxlovid treatment and discontinued on 04-MAY-2022.  After 5 days, on 08-MAY-2022, the patient's symptoms of sore throat, sinus pain and nasal congestion returned (it was not clearly reported when the patient had experienced the symptoms previously) and she tested positive for Covid-19 rapid test (dose number in series 2). The patient did not receive any treatment and was not hospitalized. Laboratory data included: COVID-19 rapid POC (point of care) test (NR: not provided) positive. Laboratory data (dates unspecified) included: EEG (NR: not provided) abnormal (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The product was associated with a product quality complaint: 90000231592.; Sender's Comments: V0: 20220530412-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
no adverse event; PNEUMOVAX23 dose expired on 03-OCT-2021 and was administered on 05-OCT-2021; This spontaneous report was received from an office manager via company representative, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.  On 05-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter one time, lot # T021329, expiry date 03-OCT-2021, for prophylaxis. No adverse event reported.
Information has been received from a physician concerning a female who on 11-JUL-2007 was vaccinated with a 0.65ml dose of Zostavax (Oka/Merck).  On 12-JUL-2007 the patient developed a red mark the size of a quarter at the injection site which grew to the size of a half dollar, and developed a "blister looking rash".  Unspecified medical attention was sought.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. In May 1996 and June 2007 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, dosage, route and lot number were not reported). Concomitant therapy was not reported. The nurse informed that on an unspecified date (also report was recently) the patients titers were checked because of school requirement and the result was in the equivocal range. The outcome of the event was unknown. Additional information has been requested.
This customer reported DOB year at 2008 which put her in the correct age range for the Pfizer vaccine. Was notified  that when they compared vital stats on this customer her actual DOB was in 2009 which would have made her ineligible for the vaccine. Upon further review of our chart, it was realized that this customer had 2 charts, one with 2008 and one with  2009 birth year. Mother had inadvertently given us the wrong DOB of 2008. Unfortunately mother confirmed birthdate as 2008 both times she was here for COVID immunizations.  Customer did not have any adverse reaction from vaccnation
sweating; warm to the touch; joint pain; now has a temperature of 101.4; muscle aches; Headache; fatigued; chills; Still is fatigued; has a headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING HOT (warm to the touch), ARTHRALGIA (joint pain), PYREXIA (now has a temperature of 101.4) and MYALGIA (muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced HYPERHIDROSIS (sweating), FEELING HOT (warm to the touch), ARTHRALGIA (joint pain), PYREXIA (now has a temperature of 101.4), MYALGIA (muscle aches), HEADACHE (Headache), FATIGUE (fatigued), CHILLS (chills) and HEADACHE (has a headache). 28-Apr-2021, the patient experienced FATIGUE (Still is fatigued). At the time of the report, HYPERHIDROSIS (sweating), FEELING HOT (warm to the touch), ARTHRALGIA (joint pain), PYREXIA (now has a temperature of 101.4), MYALGIA (muscle aches), HEADACHE (Headache), FATIGUE (fatigued), CHILLS (chills), FATIGUE (Still is fatigued) and HEADACHE (has a headache) outcome was unknown.            Treatment drugs include Aspirin and Tylenol.
Pt took 1st oral typhoid capsule 4-30-15 with slight nausea. Took 2nd capsule 5-2-15 with nausea, vomited about 1 hr after and saw capsule in emesis. Phoned me 5-4-15 to ask what she should do. States had phoned Crucell and they told her to call med prescriber. Pt advice from Crucell advised pt if takes 3 more every other day capsules starting tday would still have 5 yr protection. Pt will pick up replacement capsule today. Advised to take on empty stomach eat 1 hr after taking should be well hydrated on days takes capsules.
Had uterine cancer; Maternal exposure during pregnancy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UTERINE CANCER (medically significant), outcome "unknown", described as "Had uterine cancer"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown". Clinical course: Caller had 4 first 4 Covid shots from Pfizer. While making appointment for new Pfizer Covid shot, reading brochure with all the side effects, wanting to know if there are more side effects with new Covid shot. With the Covid shot, have they heard of any increase of women coming down with Uterine cancer from Covid shot? Had uterine cancer, niece is pregnant, said something to her OBGYN about it, was telling her, there have been increase with women who have all ready gone through change of life with Covid shot. Told caller, she better not get any more shots.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
experiencing joint pain in my elbowd; experiencing muscle pain in my elbowd; 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 ARTHRALGIA (experiencing joint pain in my elbowd) and MYALGIA (experiencing muscle pain in my elbowd) 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.    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 ARTHRALGIA (experiencing joint pain in my elbowd) and MYALGIA (experiencing muscle pain in my elbowd). At the time of the report, ARTHRALGIA (experiencing joint pain in my elbowd) and MYALGIA (experiencing muscle pain in my elbowd) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
11JUN was the first shot & 13JUN eyes rolled up & hands were shaking, T98
Next day patient had fatigue and headache and then developed hives. Currently on hydroxyzine and ZANTAC.
Fever starting on day p/shots until seen by MD on 18MAR91; Ranging fr 101-103;
In 24 hours had muscle aches, fever and headaches. After a week I broke out in hives that covered my entire body and entered my mouth. Received treatment right away and the hives stopped spreading after a week
Child received Hep A and Tdap in Lt thigh on 9/20/10. Mom reports Lt thigh became red and was sore that week. Mom reports week of 9/27/10 child complained of increased pain and redness of left thigh and left thigh had an open raised sore in center of red area. Child taken to emergency (10/5/10) - started on antibiotics.
Redness and swelling over right deltoid area 24hrs after vaccination.  Upon evaluation, symptoms spontaneously resolving; expect complete spontaneous recovery.
shoulder pain; This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a flu shot of unknown formulation years ago, that caused her shoulder pain and it resolved on unknown date. This case has been linked with US2019225256, reported by same reporter.
TOOK AN UNREFRIGERATED DOSE; A spontaneous case report was received from a physician on 11-Feb-2019 for four consumers.  Based on the information obtained from the physician, four individual case safety reports PVX201902-000103 (PVX2019-369; physician), PVX201902-000104 (PVX2019-371, male consumer), PVX201902-000105 (PVX2019-372, female 1) and PVX201902-000106 (PVX2019-373, female 2) were created and cross-linked in the database.  The report describes a 22-year-old adult female consumer who "took an unrefrigerated dose". The consumer was receiving Vivotif for an unknown indication.   It was reported that the consumer took the first dose of Vivotif that was not refrigerated.  The action taken with Vivotif with respect to the event "took an unrefrigerated dose" was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201902-000103:
Injection site numbness and pain; Injection site numbness and pain; The whole arm where injected was numb and was in pain.; The whole arm where injected was numb and was in pain.; This is a spontaneous report from a non-contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot unknown, via an unspecified route of administration in arm on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced injection site numbness and pain, the whole arm where injected was numb and was in pain. The events were non-serious with outcome of recovered: the events went away by the 2nd day.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Moderna vaccine (NDC 80777-0273-98) lot # 039D21A + GTIN 00387772783983 was administered after the beyond date of 10/232/2021.  Contacted Manufacturer Moderna = no need to repeat the dose.
Feeling tired; Strange feeling in right arm; strange feeling in his right arm that is sensitive to touch; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced tiredness, abnormal sensation of limbs and touch sensitivity increased. On an unknown date, the outcome of the tiredness, abnormal sensation of limbs and touch sensitivity increased were unknown.   It was unknown if the reporter considered the tiredness, abnormal sensation of limbs and touch sensitivity increased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. After receiving the 1st dose of Shingrix, the patient experienced feeling more tired. Last month, he experienced a strange feeling in the patient's right arm that was sensitive to touch. The patient reported no outward signs of irritation. The reporter did not consent to follow up.
LARGE AREA OF EDEMA, CELLULITIS-LIKE RASH AND LYMPHADENOPATHY IN AFFECTED ARM.  THIS WAS HIS THIRD VACCINATION IN THE SERIES.  PT GIVEN BENADRYL AND IBUPROFEN.
This spontaneous report was received from a consumer concerning her 5 year old daughter, via company representative. The patient's concurrent conditions, medical history and concomitant medications were not reported. On approximately 25-MAY-2016, also reported as "a week ago", the patient was vaccinated with VARIVAX (dose, strength, dose number, route of administration and lot number were not reported). On an unspecified date in 2016, the patient developed a swollen, itchy leg (unspecified which leg). At the time of reporting, the outcome of peripheral swelling and pruritus was unknown. The casual relationship between peripheral swelling and pruritus with VARIVAX was unknown. Additional information is not expected since no consent for follow up was provided.
Patient was given a dosage that was outside of the handling constraints required by the manufacturer.  The vaccine was mixed at 05/08/21 @ 3pm the previous date and should not have been used after 9pm.  It was used to give a dose to a patient on 05/09/21 around noon.
pt recv vax 8APR(6 & 10JUN97 pt devel a rash;
Headache, HOT SWEATS, CHILLS Narrative: STAYED HOME FROM WORK
Fever, chills, hot flashes, nausea, dizziness, swelling from my shoulder blade down to my fingertips, muscle weakness in my legs, shivering while under 4 blankets, tiredness, continuing mild nausea and motion sickness, continuing swelling of my upper left arm after 5 days
About 10 minutes after HPV vaccine administered, patient had a witness seizure-like episode (likely convulsive vasovagal syncopal event). Patient standing, eyes rolled back, leaned back, arms stiff and shaking, unresponsive. Brief (10 seconds), no urine or stool incontinence, no post-ictal period. Similar reaction with 1st HPV vaccine per mom.
Information has been received from a RN concerning a "few" patients who were vaccinated with varicella virus vaccine live. Subsequently, the patients developed chicken pox. Unspecified medical attention was sought. It was reported that other patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
At approximately 11:47, patient presented with syncope, nausea and vomiting, headache, and ear pressure.  EMS was notified at approximately 11:49 and arrived at 11:54.  Pt agreed to transport to hospital.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-JAN-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 21-MAY-2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a Certified Medical Assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with a dose of PNEUMOVAX (lot #, dose and route not reported) for prophylaxis that was stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected (Reporter refused additional contact).
3 days following injection I experienced increasing systemic inflammation triggering symptoms of Multiple Sclerosis (sensation changes, weakness, and pain), Psoriasis (scalp and face) and associated Psoriatic arthritis (joint swelling, pain and tenderness especially in the hands/fingers). History with no symptoms of MS for over 1 year and no symptoms from psoriatic arthritis for over 4 years leading up to the vaccination. Some pain has begun to fade as of today.
This spontaneous report was received from a pharmacist referring to a 72 year old female patient. The patient's current condition included arthritis. The patient's drug reaction/allergies and concomitant medications were reported as none. On 08-MAR-2018, the patient was administered a dose of PNEUMOVAX 23 (lot: N030847, expiry date: 19-JUN-2019) as a vaccination. On 08-MAR-2018, the patient experienced injection site reaction but she could not give any further description of the event. No further information provided. No PQC. Outcome and causality assessment for the event was not reported.
Day immediately following vaccine, patient was fatigued, weak, with vomiting. Day two post vaccine reported truncal rash which was itchy and red (resolved within 2 days). Day 3 patient reported palpitations and fast HR, uncontrollable HTN (160/110), been to the ER 6 times. Now taking Diltiazem, metoprolol, and hydroxyzine in addition to meds already taking.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-OCT-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K004281, expire date 22-MAR-2015; dose and route unknown). The total cumulative excursion time was 1368 hours with the lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Swollen hard red itchy patch in upper arm  appeared 9 days after first   Moderna vaccine
After I was given the antrax vaccine, I began to feel discomfort in my left arm. A couples weeks later I make an appointment with my PCP and he prescribed me cyclobenzaprine, ibuprofen and lidocaine topical, he also referred me to a physical therapy. The physical therapy told me that the member from my unit clinic hit my radial nerve with the shot, she also referred me to occupational therapy.
NUMBNESS IN BOTH UPPER ARMS AND BOTH LEGS BOVE KNEES WITH SHOOTING PAINS DOWN INNER PART OF ARMS TO ELBOW AND INNER PART OF BOTH LEGS.  SHOOTING PAINS FINALLY SUBSIDED.  NUMBNESS CONTINUES. . WENT TO DR ON 4/19/21.  NO TREATMENT GIVEN
While administering the vaccine a portion "leaked out" either from the injection site or barrel of syringe.
Dizziness; Hot flashes; Cold flashes; So much sweating; Headache; Full body soreness; Vision started to get blurred; Felt weak when standing; This is a spontaneous report from a contactable consumer, the patient.  A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 11:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 12:45 (at the age of 17-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 had not been tested for COVID-19. On 28Apr2021 at 17:45, the patient experienced dizziness, hot, cold flashes, sweating, headache, full body soreness, vision started to get blurred at the dudes and felt weak when standing. It was reported that the patient had to take the day off school because she could not get out of bed. The patient received treatment with TYLENOL for the reported events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event dizziness, hot, cold flashes, sweating, headache, full body soreness, vision started to get blurred and felt weak when standing were resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.