chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: EW0170) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Gastric Ulcers" (unspecified if ongoing); "Reflux" (unspecified if ongoing); "Pyelonephritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE; PROTONIX [OMEPRAZOLE]; ERTAPENEM. The following information was reported: VERTIGO (non-serious) with onset 12May2021, outcome "not recovered", described as "Vertigo". Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient had no known allergies. Patient diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. Patient received Amolodipine 10mg, Protonix 40mg, Ertapenem 1g in two weeks prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Pt received Tdap injection 3/17/09. 3/24/09 reported as walkin to PCP reporting that arm is red and swollen. Per NP note that day "left deltoid area has a 10cm x 8cm area of enduration with a firm center that measures 4cm.  No pustules noted.  Slight tenderness to palpation." Pt was given benadryl 25 mg every 6 hours x 3 days and Keflex 250mg every 6  hours x 7 days.
- Severe chest pain - Five hours of extreme shivering - Abnormal cramping of muscles in chest and abdomen - Unable to extend arms
I felt rushing and increased HR right away, up to 84 beats per minute and it's normally 74 beats per minute. I have heart problems so I try to keep track of it. The first injection I also had an increased heart rate. I felt these symptoms on day one and early day 2. On day 2 when I woke up I started to feel fatigue and I was really tired I had to go to bed earlier than usual. I continued to have fatigue and mild headache behind my eyes through the bridge of my nose. I've had trouble with stuffy nose, and my stuffiness went away, I stopped taking Mucinex, I had GI symptoms and had dark stool on days 2 and 3. I had cramping and on April 1 I got unbelievable pain in my left knee and left elbow that went away on 4/2 and on that day I had pain in my left hip and I could hardly move, that pain continued until the 6th. I've continued to have pain in my left hip but it's not as bad. Dr. thought the hip pain was not due to the vaccine. The knee and elbow pain may have been related.
pt recv vax 24DEC96 & started w/severe h/a, n & T100.0 lasting 3 days;this was followed by a few months of reoccurring h/a;AUG97 pt local muscular atrophy @ the site of inj  appear to be fat necrosis;pain down rt humerus & fatigue;
Egg shaped and egg size local reaction at injection site; red, swollen, warm, tender.
This spontaneous report was received from a registered nurse via company representative refers to a 13 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date, the patient was vaccinated with (total three doses) GARDASIL, (dose, unit, expiration date and lot number not specified) intramuscularly as prophylaxis at an unknown age. On an unknown date, the patient developed lupus (systemic lupus erythematosus) at age 13, (exact date of diagnosis not provided), and had an abnormal pap smear on an unknown date in 2015. It was unknown, if lab diagnostics/studies were performed. It was unknown if patient received treatment for the adverse event. The patient sought medical attention. The outcome of the events was unknown. Causality assessment was not reported. Product quality complaint was not involved. Upon internal review, the event systemic lupus erythematosus was determined to be medically significant.
My son was given the GARDASIL 9 vaccine NDC#0006-4119-01 Lot #M016193 MFR Merck and Co. and an adverse reaction to the shot. He was diagnosed with PANDAS disease 6 weeks after being given the shot. He recently had IVIG treatment to help with his symptoms.
fainted & mild sz <30 secs; no loss of bowel/bladder control; seen by MD & released;
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 10:00 (Lot number: EN6204) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot (last one was 2 years ago, it was the Flu shot and she had no reaction). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 16:00, outcome "recovered" (2021), described as "sore arm".   No follow-up attempts are possible. No further information is expected.
About 15 minutes after receiving the vaccine, the patient reported itching. Patient reported whole body itching and hands were shaking. Patient was given 10ml of liquid Benadryl and EMS was called. EMS arrived on-site. Patient was still itching. EMS requested second dose of liquid Benadryl and advised patient to go to hospital. Patient refused to go with EMS, instead called mother to pick her up. Patient confirmed she also has anxiety.
Deep nerve type pain on left side of face, eye pain,  sensitivity to light, dizziness, headaches, numbness and tingling in right arm and leg and one occasion of numbness and tingling right side of face, shortness of breath, heart palpitations, back and neck pain, brain fog, and fatigue.  Initially thought facial pain was due to nose injury even though nose injury resolved and no pain present until vaccination. MRI of face completed which revealed no significant findings. Blood work was normal. I was then worked up for Multiple Sclerosis. Brain MRI in August of 2021 revealed encephalomalacia, but did not indicate MS. Lyme disease- negative. Autoimmune diseases-negative. Cervical spine MRI-Normal (11/5/21)
Flushing/sweating.  BP 97/54, HR 78, RR 22 -- > 101/60, 87, 18.  Pt stable and released from the vaccination site.
Patient presented to ER at 8:24 pm on 1/21/05 with fever and leg swelling in right thigh.  Child had received Pneumovax vaccine yesterday (1/20/05) in right thigh.  On 1/21/05 in the am patient had minimal swelling, redness and tenderness present.  Redness, pain, and swelling increased throughout the day and fever developed.   Patient now walks with limp due to pain.  Admitted to hospital and was treated with Acetaminophen for the pain and cefazolin for the infection. Was on cefazolin IV for 2.5 days.  Over weekend patient clinically improved with redness and swelling decreasing.  He was discharged on 1/24/05 with a prescription for 7 days of oral cephalexin. Medical records received on 4/20/2005 states cellulitis and injection site reaction.
Patient called me the day after the administration complaining of Headache, Fever, Chills, Loss of apetite. I explained that she was experiencing a rash or trouble breathing. She explained that she just felt ill. I explained that if the symptoms did not get better that she should go in to see her physician. She called me yesterday to explain that she is going to see her physician.
Redness, pain, swelling at injection site. Unable to lift arm above shoulder. Treatment: Ibuprofen and ice.
Patient received 2nd dose too early per CDC Guidelines. Patient is aware and discussed with nurse. Per patient he is not severely immunocompromised to receive another dose.
Received TD,MMR and TD skin test on 08/22/2005 on 08/23/2005 arm started swelling, got red, hot and fever on 08/24/2005 stayed home, left arm painful, stated still had knot but was much better today 08/25/2005 used ibuprofen, warm packs and cold packs.
Patient c/o "bones hurt, headache, hot then cold, stomach hurts, can't hardly walk, not sure if running temp" (has not taken temp). PHN asked pt how her arm was, pt stated it was fine. Pt states she called E.R. and was told to call Health Dept because she was having a reaction to the tetanus shot. Pt states cannot be seen at PMD today but mother will take her to E.R. today.
The report was first received from practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 20-NOV-2017, the patient was vaccinated with improperly stored ROTATEQ (strength were unknown, lot# M042169 and expiration date 22-JUN-2018) 1 dose form orally for prophylaxis. No adverse event was reported. The excursion temperature on 08-NOV-2017 and 16-NOV-2017 was 47 degree Celsius for max 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Headache Narrative:  Employee reported severe headache 1/20/2021 and 1/21/2021. Moderate headache 1/22/2021 and mild headache 1/23/2021. Resulted in 3 hours unable to work 1/20/2021 and 2 hours unable to work 1/21/2021. Did not seek medical attention for the symptoms.
Within two to three hours, I reacted with chills, fever, weakness, fatigue, soreness at vaccination site, waves of nausea, joint soreness. I can only remember a couple of times in my life ever feeling so sick. Within 24 hours my side effects subsided. Ten days later I developed itching and burning on hands, arms, chest and neck which, when scratched, turned bright red. The rash  lasted  about three of days.
Fever 4 days after vaccinations, then again 10 days after vaccination up to 103 degrees rash that is macular 10 days after vaccination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (28Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: positive tests; (28Apr2023) Negative, notes: tests had been negative since 28Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300178219 same patient, different drug/ event;
was administered her 2nd dose of the Hepatitis B vaccine in 1997; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 27-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received 2nd dose in 1997).   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 3rd dose of Hepatitis B vaccine, which led to incomplete course of vaccination. The pharmacist had minimal information about the patient and was unaware of which Hepatitis B vaccine the patient received. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Started April 3rd, lasted until Wednesday April 6th. Extreme sore throat,  sever joint pain, could not sit up or get out of bed without help, could not lift a glass of water to take medicine, could not dress myself, fever of 102 and 103, couldn't eat, slept 18 to 20 hours a day.
This patient denied ever have recieving any COVID-19 vaccination.  The Moderna Vaccine was given as what was though to be #1 in the series.  When this vaccine was entered into the system it was observed that the patient had recieved the Pfizer vaccine on 3/19/2021.
1616: Vaccination 1630: C/o throat swelling and scratchy throat. Denies pruritis on body. Hx of food allergies with same symptoms. Usually takes Benadryl with relief. 1632: Benadryl 25mg PO 1653: Benadryl 25mg PO 1730: Pt reports symptoms have improved but usually takes a little time to resolved. Awake, alert, oriented, smiling, laughing. No distress noted. Informed Dr. who stated that okay to send home. Informed pt to seek medical attention as needed and then report to COVID hotline. No addition adverse reaction recorded in EMR
Information has been received from a physician concerning an 11 year old male who on unspecified date was vaccinated with a dose of VARIVAX (Merck). On 11-JUN-2010 the patient experienced shingles despite receiving VARIVAX (Merck). No lot number was provided. The patient sought unspecified medical attention. The patient's shingles persisted. Additional information has been requested.
Case number PHEH2013US013486 is an initial spontaneous report received from a nurse on 20 Jun 2013. This case refers to a 29-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the first three doses of post-exposure series of RABAVERT (batch number: not reported) intramuscularly on 06 Jun 2013, 09 Jun 2013 and 13 Jun 2013 respectively. After the third dose was administered on 13 Jun 2013 at 10 am, the patient experienced tachycardia, shortness of breath, and a sore arm without swelling. The patient did not take any medications to lessen the pain. The final outcome was reported as unknown. The seriousness and causality were not reported.
appears weak, limp, 1 day p/shots; high fever 102; slept most of today; imp: hyporesponsive reaction;
About 4 hours after vaccines, child had redness of entire right thigh where Hib and Prevnar were given. Had episodes of screaming then sleeping for 4 hours after redness noted. Redness lasted about 1 hour.
I took care of my 4- and 2-year old granddaughters who had caught a cold from their mother. I caught the cold too, exhibiting fatigue, head congestion, sinus drainage, and cough. I began to feel better in 2 days, then about 4 days in I felt sick again. August 8 I took a quick, home COVID-19 test that was negative. Thirteen days after becoming ill, I saw Dr. He prescribed Mucinx decongestant and cough suppressant and a Z-pack. I got better, especially in terms of energy level. I still have some congestion, sinus drainage, and cough.
Several hrs p/vax, PT became lethergic, limp & febrile; developed "jerking motions" lasting 10-15 sec followed by passing urine, then sleep;
Allergic.. Swelling of face, hands, and feet. Benadryl corrected reaction.
Symptoms starting 11/06-11/07: Muscle aches, fever, sweating, headache  Symptoms remaining 11/07: mild headache and some sweating
Patient ran a fever (101-102F) after immunization. Patient also had a site reaction (redness and swelling), but since both injections were in the same arm, it cannot be determined which caused the site reaction.
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. The patient's healthcare provider(s) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 05-DEC-2012, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-FEB-2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Information has been received from a health professional concerning a patient in third grade who was vaccinated with a dose of Varivax. On 27-APR-2006 the patient experienced shingles. Additional information has been requested.
Approximately 4 hours s/p vaccination administration, patient started to experience a headache, nausea, radiating heat, and redness/swelling at site.  After 7 days post vaccine, patient reports feeling numbness and loss of sensation at site.
This spontaneous report received from a pharmacist referred to a currently 51 year old female patient. The patient did not have any medical history or allergies. Concurrent conditions and concomitant medications were not reported. On an unknown date, the patient received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (lot and expiry date not reported). Pharmacist reported that the patient recently on an unknown date, had blood work as a prerequisite for employment, and the blood work revealed negative titers for measles, mumps and rubella (Antibody test negative). The patient then received a dose of MMR II (unknown lot/expiry date) reconstituted with sterile water diluent (unknown lot/expiry date) on 02-JUN-2017 because she had negative titers from the first dose. Outcome and causality for the event was not reported.  Additional information has been requested.
Child immediately turned very pale (whole body) after the last injection. Child was not limp & pt was responsive. This episode lasted about 5 min, pt was checked by MD & breathing was ok. Pt is a twin. Child is doing well, and continuing his vaccines.
Starting at 9am, had jaw pain, that subsided, nausea at dinner, severe chills when I went to bed, generalized fatigue and body aches throughout the day and night and continue to still have both
PATIENT INADVERTENTLY RECEIVED THE VAXELIS VACCINE.  The patient was examined the following day with soreness to injection site noted,  but no other signs of reaction. The vaccine was given on 12/01/2022 at approximately 1600.  The child was examined on 12/02/2022 around 0815.
Erythema, swelling, warmth and pain (L) AE allergic vs cellulitis.
I do not have access to the lot number etc. i spoke with the Dr on the phone, he verified Men B was given in left arm. MCV in right arm-- and his staff stated they did not know how to report in this system. I saw pt today at my site. His left arm had a raised, red, painful, and warm to touch spot that started on the lower end of the deltoid just in front of the injection site. The raised red area measured 10.5 cm tall by 6 cm wide. He declined benadryl due to the side effects. He accepted ice to site. No swelling of tongue, lips, throat, or respiratory distress. Right arm was not affected. Phoned Mom and Dr and informed them of findings. Marked edges of site affected with small black pen marks so pt and mom can assess if swelling or redness increases. Pt has an appt with Dr on 1/11. Informed mom and Dr if swelling worsens he should be seen earlier.
Shingles; Information has been received from a lawyer concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In 2017, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, route, lot number, expiration date, and anatomical location were not provided) at physician's office, for long-term prevention of Shingles and zoster-related conditions. Subsequently, the patient was treated by the physician for shingles. As a direct and proximate result of patient's use of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity of the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the patient had not recovered from the event. The reporter considered the event as related.
I got the shot and then a month ago I got shingles/ Suspect vaccination failure; I got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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 reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated that she/he got the shot and then a month ago from the time of reporting the patient got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.