chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient reported that, shingles could not be prevented. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Started with a rash yesterday afternoon on the face and chest.  Has small dots all over forehead and along the cheek can jawbone.  Itchy and also has welts all over her body. Took Nyquil for some relief last evening.  Plans to take Benadryl today to help with the welts, rash, and itching.
Severe global myalgias arthralgias headaches mild sublingual temp increase to 100.0 F
Patient received Pfizer-Biontech (monovalent) NDC # 59267-1025- 04  instead of the intend bivalent (NDC #59267-0304-02)
Was given 0.25ml but immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Was given 0.25ml but immunocompromised) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 001A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (The right lung was removed due to cancer) and Lung operation NOS (She has one lung (the right lung was removed due to cancer)). Concurrent medical conditions included Hypertension.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Was given 0.25ml but immunocompromised). On 26-Aug-2021, ACCIDENTAL UNDERDOSE (Was given 0.25ml but immunocompromised) had resolved.            No concomitant medications were reported. No treatment medications were reported.
pt recv vax 30JAN98 & w/in hr arm became very red, swollen & painful;the center of area was raised & appeared blistered;axillary lymph nodule enlarged & painful;eyes became swollen & cold like sx began;pt feverish but did not take temp
Headache; Cold chills; Body aches; numbness in my left arm where I get the shot like a kind of stands from where the shot was till the fingertips; Weak; Fatigue; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "Headache"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "Cold chills"; PAIN (non-serious) with onset May2021, outcome "unknown", described as "Body aches"; HYPOAESTHESIA (non-serious) with onset May2021, outcome "unknown", described as "numbness in my left arm where I get the shot like a kind of stands from where the shot was till the fingertips"; ASTHENIA (non-serious) with onset May2021, outcome "unknown", described as "Weak"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "Fatigue"; MYALGIA (non-serious) with onset May2021, outcome "unknown", described as "Muscle pain".  Additional information: The manufacturer of Covid-19 Vaccine was unspecified. The patient stated he was just reporting some side effects from his second Pfizer shot. He stated, "I already filled that on the website while I was on hold. I didn't have any take like in suggestion to do anything". You know they just kind of took information any thing they didn't tell me if you know I can take Tylenol or some sort of medicine or something. Consumer further stated, "I already filled the report on the website so I don't think I should filled on another one you know. When asked to probe few questions, consumer stated "I mean if you are filling the report again I mean that will be double filling because I already filled it out I went to website." Date when shot was administered, he stated, "Yesterday"(Confirmed as 4 may and not further clarified). Product details and pharmacy details could not be probed as the consumer was unwilling to complete the report. Hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site redness, warmth and swelling; Injection site redness, warmth and swelling; Injection site redness, warmth and swelling; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; en6206) via an unspecified route of administration in the left arm on 09Mar2021 at 11:45 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and hypothyroidism. The patient had known allergies with past drugs naproxen and pentosan polysulfate sodium. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. On 09Mar2021 at 12:00, the patient experienced injection site redness, warmth and swelling spreading 16 days following injection. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site erythema, vaccination site warmth and vaccination site swelling was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
Patient received 2nd dose vaccine on 4/1/21 and on 4/22/21 complained of intense arm/shoulder pain radiating to chest. Pain persisted for about 2 -3 days and was resolved around day 4
Pt was given 4 month vaccines without complication. No illness. Fell asleep in car seat. Approximately 1/2 hour later, pt woke. Eyes were open and glassy, all body had jerking forward and backwards lasting 7 seconds.  Afterwards, pt then acting normally. Seen in office approximately 1 hour after episode- fully normal exam. No fever.
Nerve pain, vomiting, headache, weakness, nausea, fatigue, abdominal pain, bloating, early satiety, increased heart rate, irregular heart rate - all symptoms constant in afternoon/night - zofran odt for vomiting and nausea, midodrine for headache, methocarbimol for pain
Rash x 3d mostly on abd. T increase 102 degrees 11/29 pm.
Onset of blisters and itching in face that progressed over a period of one week into a full blown case of shingles. Patient never had shingles in past.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 56-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). On 17th April 2018 13:25, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, feeling unwell, swelling arm and fever. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain, feeling unwell, swelling arm and fever. On an unknown date, the outcome of the pain, feeling unwell, swelling arm and fever were recovered/resolved. The reporter considered the pain, feeling unwell, swelling arm and fever to be almost certainly related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, the patient experienced big swelling in a large area that took up most of his upper arm part. The patient experienced achy, feverish and crappy feeling after receiving SHINGRIX. The healthcare professional is not sure when the symptoms had begun but when the patient came in a couple of days later to pick up other prescriptions, they were resolved, there was no swelling visible. No other vaccines were concomitantly administered to the patient. This was linked to case US2018084304, reported by the same reporter.
Patient stated that about a week and a half after receiving 2nd dose of Moderna vaccine, that he started feeling a tingling feeling that lead from his ear to his shoulder. Patient stated that the feeling will last about 15-20 seconds then stops. Then it starts happening again after about 20 minutes. Patient also stated that over the past few weeks, the feeling hasn't gotten more intense and there is no pain but it is happening more frequently. Patient stated that he has been to 2 different doctors and neither could find out what was happening or why it was happening.
Experienced 5 seizures; Patient had Comirnaty and Moderna vaccine; Patient had Comirnaty and Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Experienced 5 seizures) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    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 and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Experienced 5 seizures) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine). At the time of the report, SEIZURE (Experienced 5 seizures), INTERCHANGE OF VACCINE PRODUCTS (Patient had Comirnaty and Moderna vaccine) and COVID-19 IMMUNISATION (Patient had Comirnaty and Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment information was reported.  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. Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Seizure (reported as experienced 5 seizures) after receiving a dose of mRNA-1273 vaccine on an unknown date and co-suspect drug Tozinameran. Latency cannot be assessed as the vaccination date and onset date of event were not provided. Clinical course and treatment details were not reported. The outcome of event was unknown. The co-suspect Tozinameran could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Seizure (reported as experienced 5 seizures) after receiving a dose of mRNA-1273 vaccine on an unknown date and co-suspect drug Tozinameran. Latency cannot be assessed as the vaccination date and onset date of event were not provided. Clinical course and treatment details were not reported. The outcome of event was unknown. The co-suspect Tozinameran could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.
pt recv 2 dose of vax & failed to seroconvert;no further details were provided;
Pt received 4mo shots on 5/28 at approximately 12pm. That evening she had a mild fever and rcved TYLENOL. Mom noticed some mild twitching while she was nursing. On 5/29 approximately 2pm, she had a T 101.8 (temp scanner) and when dad laid her down, her arms and legs twitched and eyes rolled back for a few seconds.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M004116 with expiration date 12-OCT-2017, (dose number and route of administration were not provided). No adverse effects were reported. The vaccine experienced a temperature excursion of 30.9 F for 18 hours. There was a previous excursion of 48.9 F for 23 hours. No data logger was involved. Additional information has been requested.
The patient was only 17 year old at the time of vaccination. She works in a dental office.
pt recv vax; devel rash,covered most of body;devel unspecified infection;tx w/ diphenhydramine, cephalexin, dexamethasone & methylprednisolone; recovered on 9jun94;
Side effects from first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects from first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects from first shot). At the time of the report, VACCINATION COMPLICATION (Side effects from first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication  were reported. No treatment details were reported.
Headache, Fever, Nausea Vomiting, CHILLS Narrative:
p/vax pt devel chills & fever 101.5 for 48hr achy & chills Friday 10/22/99 felt OK;
Pt stated he developed a rash on right knee that began to spread across legs. Pt went to his physician and was instructed to take cimetidine 800mg every 12 hours as well as hydroxyzine 25mg every 6 hours.
Patient called on 10/23/19 with complaints of fever and chest pain.  advised to go to the ER.   patient went to EX-press care on 10/26/19 with complaints of rash on torso, R arm, face and L arm, with itchiness.  Also complaining of localized redness at injection site.  Patient then went to the ER on 10/28/19 with complaints of an itchy rash and headache.  Patient noted to have a few macular papular lesions on face, head, neck  and torso, without drainage.  Afebrile
I was positive for COVID-19 on 30JAN2023, I did not have a fever, I started getting a scratchy throat and cough. I lot of phlegm and congestion, sore throat for a day. Body aches and the cough went on for 2 weeks.
Chills, shaking, cold, sleeplessness - 12 hrs after vaccination for a period of at least two hours.  Exhaustion, fatigue, diarrhea for next three days after vaccination
Shingles: Multi-dermatome Lumbar. Treated with acyclovir and steroids.
23 weeks at time of 2nd dose. Due date is Aug. 12, 2021
Shots (MCV4 + Hep A) given in Left arm on 3/20/06. Mom brought pt back in today 3/22/06 with left arm swollen, red and itchy.
Pt stated that she developed pustules, itching, rash/hives all over her body (especially down the arms and including the face). She stated she also had a fever. These side effects began three days after receiving the vaccines (shingrix and fluzoneHD). She treated the reaction with Benadryl and cool baths and limited the amount of clothing over the affected areas.
hives around the chest area; redness around the chest area; A spontaneous report was received from a pharmacist,  concerning a 42-year-old female patient who developed hives around the chest area/urticaria and redness around the chest area/erythema.  The patient's medical history is unknown. Products known to have been used by the patient concomitantly is unknown.  On 11-MAR-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.     On 11-MAR-2021, the patient experienced hives and redness around the chest area resulting in hospitalization. The patient was prescribed prednisone.  Action taken with mRNA-1273 in response to the events was not applicable.    The outcome of the events, hives around the chest area/urticaria and redness around the chest area/erythema were considered as unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
The night before I felt like my allergies were acting up but by the morning. I had mostly chest congestion, upper respiratory and lots of body aches and my bones ached. I tested on in December and it was positive. I called my doctor and he prescribed Paxlovid. I took Mucinex for the other symptoms. Within 48 hours I felt better. I have since seen the doctor for long COVID symptoms like exhaustion and a foggy mind periodically. I was advised that there is not any additional treatment that can be provided. Diabetes has come up since I had the vaccine also. Round the 1st part of January 2023, I went in for my annual routine bloodwork and my A1C showed up as 7.2 on January 04, 2023. I was diagnosed with Diabetes and prescribed Glimepiride and a glucose monitoring system was provided.
On 3/29/02, received call from pt with complaint of redness, swelling approx. 3" in diameter surrounding Smallpox site with tenderness in axillary area, headaches and body aches. Rx'd with Augmentin 875mg 1 po bid (10). On 4/1/02, evaluated in office. Had erythema, swelling, 1/2cm lymphadenopathy of axilla, scab formation, streaking from site to anterior axilla. Continue on Augmentin. On 4/4/02, F/U visit; erythema resolved, lymphadenopathy resolved, scab formation but no streaking. Denies headaches and body aches.
12 days/p vaccination, developed maculopapular rash on face, arms & legs. Became jumpy fussy, had fever 104 F- hospitalized, sysmtoms persisted for approx. 4 wks, subsequently rash became pigmented, DX as vasculitis
The pt developed rash, papules, few vesicles on mouth, genetaliz, few on legs, hand and inside lower lip. Also small ulcer at pillar noted.
Immediately upon awaking and trying to stand up, I noticed my legs and hurt and it was unpleasant to stand up. Later I had a fever of 100+, was very achy all over and really had a very hard day.
Red raised bumps all over body. 30 papules: face, arms, legs, and trunk.
This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a licensed practical nurse concerning a 29 year old female (also reported as 28) who on an unspecified date was vaccinated with a first dose of Gardasil 0.5mL injection. On 29-MAY-2007 the patient was vaccinated with a second dose of Gardasil (lot# 658558/1061U) IM in the left deltoid. On 29-MAY-2007 the patient experienced tenderness at the injection site. The patient also had a pea size nodule present at the injection site lasting months after the injection. Medical attention was sought. The patient's tenderness and pea size nodule at injection site persisted. No further information was provided. Additional information is not expected.
Patients claims immediate pain at injection site on right arm, could not lift right arm all weekend, blotches on right arm. Patient claims can lift arm higher today (11/2/2015) and that blotches are still present on the right arm.
Back pain, chills, fever, headache,  very  hot and itchy injection sight..also red and swollen, lethargic lasted 24 hours felt much better following day.
2 days p/vax pt exp gen itching;no rash was present;pt also exp resp sx similar to seasonal allergy sx;
Injection site very swollen, red and hot. Itchy too. Injection site is documented to be Pediarix.
Moderna administered to 16 year old patient by staff inadvertently. After mistake was realized, family was called and notified. CDC guidance reviewed and patient will be scheduled to proceed with second dose of Moderna.
Acute bilateral pulmonary embolus and right lower extremity DVT.   No typical risk factors such as recent trauma or surgery and no personal history of DVT/PE.  Received Moderna COVID-19 vaccination series in February and March of this year.
Not chills like flu; didn't feel cold; Had uncontrollable extreme shaking of entire body and limbs for two full hours resulting in sore spine and headache plus sore neck (so bad I wept).  Sore muscle in left arm on and off for two weeks, at times extreme pain that subsided only with Advil.
11/4/21 presents to local ED "cough, has been feeling weak".  PMHx "of HTN, hypothyroidism, myasthenia gravis, osteoporosis".
Menstruation - three periods in May (each time it lasted 7 days with period cramps and I took pain killers).   In June it was back to one normal cycle. My doctor had just told me to keep an eye on it.  Later, I had teeth symptoms in October. I had pain in the teeth, gums and face for a week after getting a new mouth guard. I also took pain killers, and the dentist adjusted the mouth guard and that helped with the symptoms.
Is been 3 years since the 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 3 years before date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's Comments: A nurse mentioned during a Medical Information chat if a patient missed the second dose of shingrix and it had been 3 years since the first one, do they need to restart or was ok to give second dose. The reporter ended chat after providing this information.  No further information including consent to FUP was provided by the reporter. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with the case US2021AMR172461, reported by the same reporter.