chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated at a health facility, for the onset of a severe vesicular rash, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for 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.
24 hours after shot my arm swelled a bit and was sore. I also came down with  headache, body aches, nausea and fever.   I could not  get off of couch for two days I was so ill, worse than when I had covid in November.   Then within a week or so I started having a tickle in my lungs and a cough.  I went to Dr and got an inhaler.
8/14/21: patient brought to ED as she was found unresponsive by family last time was seen was 8:00 p.m. on arrival to ED patient has to be intubated for low GCS round 3 stroke alert team was activated head CT is negative chest x-ray significant for right upper lobe mass patient required norepinephrine as she was hypotensive. COVID test PCR came back positive. admitted to COVID unit  Note: patient previously vaccinated with Pfizer Covid-19 vaccine on 4/26/21 & 5/17/21.  Diagnosed with hypoxic respiratory failure secondary to covid pneumonia.  8/22/21: patient died.
Father of client visited clinic on Thursday, March 4th 2010 and c/o that his entire family including above client has had chest congestion, runny nose, aches, on and off fever, since receiving H1N1 vaccine. Client has not been seen by a medical doctor about these signs & symptoms.
Patient received one dose of Spikevax on 10/27/2023 and today on 10/28/2023 his wife contacted us and said that patient had a little bit of soreness at the site of injection, later fever and later during the night he went into cardiac arrest and passed away.
Night sweats; No appetite; Stomach nausea; Fatigue; Complete muscle ache and body ache from her head to her toes; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), NAUSEA (Stomach nausea), FATIGUE (Fatigue) and MYALGIA (Complete muscle ache and body ache from her head to her toes) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), NAUSEA (Stomach nausea), FATIGUE (Fatigue) and MYALGIA (Complete muscle ache and body ache from her head to her toes). At the time of the report, NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), NAUSEA (Stomach nausea), FATIGUE (Fatigue) and MYALGIA (Complete muscle ache and body ache from her head to her toes) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Initial pregnancy report received from a health care professional on 17 October 2012. A 31-year-old female patient, whose concomitant medications and medical history were not reported, had received an intramuscular first dose of ADACEL vaccine (lot number: U3957DA) on 17 October 2012. The patient was pregnant at the time of vaccination. The patient's last menstrual period (LMP) date was 31 March 2012 and Expected date of delivery is (EDD) 10 January 2013. At the time of the report, the patient had not experienced any adverse events. At the time of this report, the patient's outcome was unknown. Follow-up information was received from a health care professional on 03 September 2013. Based upon new information received, this case now meets seriousness criteria and it has been upgraded to serious (chorioamnionitis). Relevant illness during pregnancy/ongoing was reported as chorioamnionitis and PP HTN. In addition to ADACEL, the patient also received AFLURIA concomitantly (lot number, route, site and date of administration not reported). Maternal history noted one previous pregnancy with a normal outcome. On 03 January 2013, the subject delivered a normal infant. Outcome for the mother was not reported. Documents held by sender: none.
8/30/2007 from patient's mother 2 hours after shot HA, bluish around mouth, legs and warm shot was given took to ER, achy all over. MD saw said flu-like symptoms, sent home ignored everything she tried to tell him. O2 level was okay, B/P increase 100/60 to normal for prior his eye. C/O  tired, achy, bluish legs when increase left arm very painful bluish, no fever, chills, no difficulty breathe, no appetite encouraged fluids, Tylenol for pain. 8/31/07 Took to ER for blood work, with cyanosis, no H/A, achy, fatigue sent home negative 8/30/07. Today no HA, left arm / -- painful. He is less achy, no H/A, continue tired, sleepy, bluish at times.
I was sore in the right arm. But I had a horrendous ringing and loss of hearing in my left ear. I have seen a doctor for it regularly since then. I had a surgery to let pressure out of the ear.
Face was paralyzed; A spontaneous report was received from a consumer concerning a 42-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis.  The patient's medical history was not reported.  Concomitant medication history was not provided.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number:  029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient woke up to find that his face was paralyzed.  The patient went to the urgent care center and they referred him to the emergency department at the hospital.  After numerous tests they diagnosed him with Bell's Palsy.    Treatment for this event included prednisone and doxycycline.  Action taken with mRNA-1273 in response to this event was not reported.  The outcome for the event, facial paralysis, was unknown.; Reporter's Comments: Based on the 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
Swollen, painful joints (particularly knee caps & joints). Low grade fever 99.7 started ground 3:00 p. 11-1-11. By 5:00 p. Same day, fever 101 & at 8:00 p. fever 102. Temperature not back to normal until late p.m. on 11-4-11. Joint pain less, but not gone as is swelling of the joints.
Client reported to Rn that 3 days after receiving the 1st COVID vaccine Pfizer she developed breast tenderness and menstruation for 3 days. The client stated this was abnormal for her as she had experienced her regular menstruation the 3 days prior to receiving the vaccine. The client also developed redness around her right cornea, which she described as a "blood vessel pop." The client stated the redness lasted about 3-4 days. The client denied any pain associated with this. The client also stated she developed fatigue that lasted one week. The client took Tylenol for her symptoms. The client denied an dizziness or shortness of breath. The client did not follow up with her primary care provider or an allergist. The client has a history of a high ANA which she manages with diet and follows up with a rhuematologist regarding her ANA level every 6 months. The client takes vitamin D and Iron supplements regularly. The client has a history of of a rash after consuming oysters.
No adverse effects; patient received the "1st dose" of GARDASIL 9 at the age of"13" in "2016" and is in the office "7/31/2019" to be administered the "2nd dose" of GARDASIL 9; This spontaneous report was received from a physician assistant and refers to 15-years-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown date in 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis at the age of 13. On 31-JUL-2019 (also reported as 2 years later), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose and route of administration were not reported, lot # N021475 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 31-JAN-2020) for prophylaxis. No adverse effects were reported.
2 weeks after flu vaccine, developed erythema multiforme-like rash, fever, joint swelling.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Patient started to have tingling on feet for few days and it spreaded through her body and also had tingling and numbness for
patient accidently got a second dose of pfizer bivalent vaccine.patient observed with no adversed effects noted.
approx 3MAR93 mom noted nodular lesion(s) under skin, upper deltoid (?) area, near the shoulder, rt arm; pt had outpt surgery for removal of nodule 10MAR94; some pus noted center of nodule; Benign for CA; unk orgin, per pt;
Call received from patient today informing staff that after vaccinations received on Tuesday 8/6/19 , that she began to feel dizzy, and weak.  Contacted patient to follow up regarding concerns, patient stated " After I received the vaccines on Tuesday, in the evening around 10:00pm I began to feel really weak , head pounding and dizzy." "The dizziness was not that bad today, but I am still feeling weak." Patient denies any other complaints, advised if symptoms persist or worsen to go to nearest emergency room.
increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increased blood pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced BLOOD PRESSURE INCREASED (increased blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (increased blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure increased: 135/190 (Inconclusive) Patient reported blood pressure increased, from about 135 to 190 systolic..         No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Patient felt light headed and experienced numbness in his left arm. He reported that his left ear "felt clogged". He was sweating and appeared pale. He did not experience nausea. (observed by pharmacist at 5:10pm)
Information has been received from a nurse practitioner concerning a 23 year old female who on 08-JUL-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL. Concomitant therapy included YASMIN. After receiving the dose the patient developed swelling on her arm at the injection site and a red and swollen index finger on the same side that the injection was given. The patient had sought medical attention, phone call. The patient had recovered on an unspecified date. Additional information has been requested.
Recurring chills, headache, myalgias, arthralgias which started 1 day after receiving flu vaccine.  Sx persistent at 2 weeks.
After vaccine wouldn't latch on, 12/21 worse, decreased tone & movement on 12/23/11, lost reflexes (gag, Moro, DTR) & improved to date 50-60% to baseline.
fatigue; chills; slept 12 hours that night / On the second night she slept 11 hours; pain at the injection site; swelling at the injection site; redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received in October 2019, refer case US2020021626.).   On 3rd February 2020, the patient received the 2nd dose of Shingrix .5 ml. On 3rd February 2020, less than a day after receiving Shingrix, the patient experienced fatigue, chills, sleep excessive, injection site pain, injection site swelling and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue, chills, injection site pain, injection site swelling and injection site erythema were recovering/resolving and the outcome of the sleep excessive was recovered/resolved.   It was unknown if the reporter considered the fatigue, chills, sleep excessive, injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows:  After receiving 2nd dose of Shingrix that evening the patient experienced fatigue and chills. The patient was slept 12 hours that night but was able to function the next day.  On the second night she slept 11 hours and the chills were reduced. The patient also experienced pain, swelling and redness at the injection site the first night. The injection site reactions were worst the 1st night and started to reduce in intensity by the second night. The 2nd day injection site area experiencing these symptoms increased in size but the pain, swelling and redness reduced in intensity. Consent to follow up was denied.
Information has been received from a physician concerning a female who on 05-DEC-2008 was vaccinated with her first dose of ROTATEQ (lot# not provided) at the age of 5 months. No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
developed Erythematous, slightly itchy rash in 6 inch by 6 inch right forearm extending inferiorly and laterally  from injection site
non erythematous papular rash clustered around vaccination sites within  2 days and itchy at only Tdap site also
allergies due to the wind blowing outside; started having runny nose; sneezing; itchy eyes; This is a spontaneous report from Pfizer sponsored program and medical information team. A contactable consumer (patient herself) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 13Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, caller (name) reported that she received the 1st dose of the vaccine last 13Mar2021 and she was scheduled on Saturday for her second dose which was 03Apr2021. She was having allergies due to the wind blowing outside and started having runny nose, sneezing and itchy eyes on an unspecified date in Mar2021. She was consulting if she could take the second dose or if she needs to wait for a while. Also, wanted to know if a person would be hurt if they take a vaccine without knowing that they got the COVID-19. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
It started almost a month after the vaccine, like a tingling attack at night. Severe tingling in lower legs at night,woke up with it. Needed to be pressed. Since then the tingling has spread to all over the body including face,lips. At times slight numbness on skin, finger tips and tip of tongue. It hasn't stopped. Reported to the doctor. *The tingling in the legs would occur at most nights for a few months before the vaccine. With compression sleeve ,it was manageable. *Low energy had started before the vaccine.
This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On January 2010 and an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown). In 2010, [See text] after vaccination with ENGERIX B, the subject experienced decreased therapeutic response.
No adverse event; Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine age Monovalent 6 mo+ administered to 2 patients on 03/15/2023 with expiration date of 02/13/2023).    No concomitant medications were reported.     No treatment medications were reported.
Subsequently developed a low grade fever and an injection site reaction characterized by redness and swelling. The pt recovered. This is 1 of 4 patients from this facility who experienced this event following receipt of Pnu-Imune 23.
Very sore arm, fever (99.6), chills, body aches, mild headache
Shingles Medication  Still have shingles on April 21, 2021 Shingles pain started after 1st Moderna Vaccine On March 12, 2021 Visual Shingles blistering  and very  painful started after 2nd Moderna Vaccine on April 2, 2021
Pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of Hep B vax on 18AUG92 w/in an hr following the vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs;
Mild weakness, exhaustion and the next side effect was severe chills that caused teeth chatters that was severe, as the chills subsided, I became feverish headache and felt flushed, started to develop a red raised welt at the injection site that was larger than normal, the entire deltoid muscle, no appetite and felt nauseated but never threw up. Pain and tenderness at injection site, lymph notes on the side of the injection site was swelling and I had pooling in the left side of my neck. When I started feeling a little better the welt in my arm continues to be painful itchy and huge.  By the 9th I was much better and back to normal, just occasionally I feel the sensation to itch the injection site and I ignore it and it goes away.
Stroke; This is a spontaneous report from a contactable Physician. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose intramuscular, administered in Arm Left on 31Jan2021 (at 66 years old), singe dose for covid-19 immunisation. Medical history included lymphoma, hypertension, polycystic kidneys. Concomitant medications included losartan potassium. The patient had first dose of bnt162b2 vaccine on 10Jan2021 (at the age of 66 years old) for Covid-19 Immunisation, via intramuscular route on left arm. No other vaccine in four weeks. The patient experienced stroke on 21Feb2021 with outcome of recovering. The patient was hospitalized for stroke for 4 days.  Information on the lot/batch number has been requested.; Sender's Comments: The event of stroke is assessed as possibly related to the suspect vaccine based on strong temporal association, but consider also possible contributory effects from patient's medical history of hypertension and polycystic kidney disease.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received PNEUMOVAX in afternoon, & by evening was experiencing "throat swelling" & needed to go to ER due to anaphylaxis.
This is a spontaneous report from a contactable pharmacist via a sales representative. This pharmacist reported similar events for 2 patients. This is the first of 2 reports. A patient of unspecified age, race, ethnicity and gender received for immunization on an unspecified date a single dose of PREVNAR 13 and a high dose of influenza vaccine.  The patient medical history and concomitant medications were not reported.  The two vaccines were co-administered on the same arm about one inch apart. On an unspecified date the patient experienced redness from the injection site all the way down to the elbow, it was red, swollen and hot. Outcome was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016586886 same reporter/product/event, different patient.
This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 24, 2021, at 01:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient felt pain on back and legs, had difficulty getting out of bed/walking around and sore on the arm. The outcome of the events: unknown. No follow-up attempts possible. Information on batch/lot cannot be obtained.