chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain all over body, headache, racing heart rate, shaking, achy, night sweats. Felt like she was going to die
Fever of 103F  muscle pain entire body joint pain, entire body,  Chest pain Tachycardia 120-130 bpm resting heart rate for 17 hours and ongoing.
Site: Pain at Injection Site-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: patient states she received flu vaccine in august, reported to pharmacy today (April) and said shes had pain in her arm since august and lymph node swelling in that arm.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. It was reported that, on an unknown date, the patient received an expired dose of PNEUMOVAX 23 (lot, dose and expiration date unspecified). No concomitant therapy was reported. No adverse events were reported. No product quality complaint (PQC) was filed. The outcome of the event was unknown. The reporter considered the events to be not related to PNEUMOVAX 23. Additional information has been requested.
Pt was given a second dose of pneumovax23, she received first dose 08/23/2020 then received a dose of prevnar13 08/10/21 so she  has completed the series
A hard raised area  became red, hot, and tender to touch. This area grew from size of a nickel to size of a baseball within 24 hours. It became hard and hot. I had chills and sweats two days, felt fatigued with general muscle aches and pain for about four days. And I had little to no appetite.  Symptoms have improved but redness and tenderness over the left deltoid persists.
This is a spontaneous report from a contactable office manager calling on behalf of a physician. The office manager reported similar events for 3 patients. This is the 3rd of 3 reports. A female patient of an unspecified age received PREVNAR 13 (LOT R19477; expiration Jan2018) via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced flu like symptoms, swelling, myalgia, fatigue. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017129381 same reporter/drug, different patient.
From initial info received on 7/8/04 from an RN regarding an adverse event occurring in the USA, it was reported that a 47 year old male pt received a TD ADS Adult vaccination, lot U1186AA, administered IM, in the left arm on 7/2/04. The same day, the pt developed redness at the injection site and flu-like signs and symptoms with chills, fever, hacky cough, aches and pain. He took Tylenol and reportedly fully recovered from these events. From additional info received on 8/19/04 from a health care professional, it was reported that there is no additional info at this time. No further info is anticipated, this case is considered closed.
Three to four days, post vax, pt complained of pain in his left shoulder, upper left arm and numbness of fingers at times. Reported to nursing supervisor who advised him to go to ER for evaluation and RX.
person devel muscular soreness & swelling lasting 4 days, @ site of inject;
Patient had redness and warmth on arm surrounding vaccination area. Redness began night of vaccination, and kept spreading. As of 5 days after vaccination, the area was still spreading, sent patient to primary care, they thought it may be infection and were treating patient with antibiotics in case of that also.
Clinical indication noted from EUA indicate that patient is required to be 18 years or older and that vaccination providers must report any errors. Noted patient was 17 years and 10 months at the time of inoculation. At the time of immunization and post observation period, patient showed no symptoms or adverse reactions. Patient to be informed to follow up with primary care provider in regards to any reactions.
Patient received vaccine at seemed ok initially. No history of adverse reaction to vaccines previously and felt ok after injection, so went to pick up prescriptions and was asked to stay in store for monitoring for 15 minutes. While checking out at counter after approximately 3 to 5 minutes, patient tensed up and passed out, falling backward and hitting her head on the floor. Patient came to within 15 to 30 seconds, but complained of being hot, slightly nauseated, and was very pale.  Patient was brought back into private health room with her mother and monitored by pharmacist and RXOM, and ambulance was called. Patient showed improvement and after EMT vitals came back normal, patient declined ambulance ride but was advised by pharmacy staff to contact PCP in regards to her reaction. Patient chose to leave after a few more minutes saying she felt ok.
3/28/21 hives developed  4/1/21 seen at Primary dr for hives 4/2/21 treated at Allergist with Prednisone and Famotadine 4/3/21 seen at ER for chills/nausea/vomiting/migraine/body aches  4/3/21 seen at ER for migraine/vomiting/nausea/hypertension crisis 4-9-21 seen at Primary dr for migraine  4-13-21 seen at primary dr migraine
cannot move her arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot move her arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced MOBILITY DECREASED (cannot move her arm). At the time of the report, MOBILITY DECREASED (cannot move her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR; Sender'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.
Within a day after receiving the initial vaccine, I began feeling somewhat fatigued. I chalked it up to old age and kept going but it didn't get better. A couple of weeks later my trainer noticed I was having difficulty breathing during our sessions. I told her I had had a lot of pneumonia as a child and my lungs were probably just getting worn out. I bought some oxygen supplementation and went on about my business. But I kept getting more and more fatigued. I was about to go see the doctor thinking I might have chronic fatigue syndrome when I caught a virus (or so I thought) in October and so I chalked up the excess tiredness to my body fighting that. But the 'virus' never went away. Usually I can kick a cold or flu in a matter of days. Whatever this was, it laid me out throughout the holidays and I was developing other symptoms inconsistent with a cold or flu such as tachycardia (my resting heart rate was 135 as opposed to my normal 78) and hypo-tension (my BP would drop to 90/60 and sometimes lower if I stood for any length of time but was a little higher 130/85 than my normal 118/75 when resting). I got the booster shot late in December and within hours, I was flat on my back and could barely walk to the bathroom without passing out. So in January I went to see the doctor.
Decreased appetite, Diarrhea, Hematochezia and fussiness.
fever, chills Narrative:  Took OTC Tylenol/Motrin. Fever of 102 degrees  Other Relevant History:
Face and throat swelling; wheezing loudly; labored breathing. 3rd morning post 1st injection, lasted 24 hours face swelling from onset; wheezing lasted 72 hours from onset (being 3rd day post 1st injection).  No medical treatment received because patient and caregiver were not warned that a DELAYED reaction to the vaccination could occur  Caregiver contacted primary doctor to report severe reactions, was asked if we sought epinepherine /ER  which we did not thinking patient had allergies, talked with cardiologist who thought patient was breathing like "an almost 90 year old".... PCP advised patient to not receive 2nd shot given 1st shot reaction.
This spontaneous report was received from a nurse regarding a 22 year old female patient. The patient had an undocumented case of chicken pox as child on an unspecified date. On an unknown date in 1993, the patient was vaccinated with M-M-R II (dose, product lot#, expiry date, route not reported) dose 1 and dose number 2 on an unknown date in 1997 and on 15-AUG-2014, the patient was vaccinated with third dose of M-M-R II (dose, product lot#, expiry date, route not reported). Other suspect therapies included VARIVAX dose 1 (dose, product lot#, expiry date, route not reported) vaccinated on 15-AUG-2014. The patient had never received VARIVAX in the past. The nurse stated that the on an unknown date, patient had titer results low for varicella, mumps and rubella. No intervention was done to prevent seriousness criteria. There was no product quality complaint involved. The outcome and causality of the event titer results low for varicella, mumps and rubella was unknown. Additional information has been requested.
Information has been received from a laboratory assistant concerning an 18 year old female patient who on 26-MAR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot #659964/1978U) and on 26-MAR-2008 she received her second dose of GARDASIL vaccine (yeast) (lot # 660393/0067X). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid). The reporter reported that the patient fainted briefly after receiving the first dose of GARDASIL vaccine (yeast). She recovered from the fainting on the same day. She did not faint after the second injection. Additional information has been requested.
No additional AE/ PQC reported at this time.; Nurse called in to report a temperature excursion that took place on 3/9/2022. Caller reported vaccines have been administered to patients. Caller reported this patient received ROTATEQ, not PEDVAX HIB.; This spontaneous report was received from a licensed vocational nurse and refers to a 2-months-old patient of unknown gender. No information was provided regarding the patient's medical history, concomitant medications, past drug reactions or allergies.  On 09-MAR-2021, the product rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1742460 and expiration date 16-NOV-2021) had a temperature excursion (product storage error). It was stated that the vaccine reached a temperature of 9 degree Celsius. This excursion had a time frame reported of 30 minutes.   On 15-MAR-2021, this improper storage vaccine was administered to the patient (concentration, dose number and vaccination scheme frequency were not provided) orally for prophylaxis.  No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA007015: US-009507513-2105USA006749: US-009507513-2105USA007032: US-009507513-2105USA007003:
having rheumatoid pain in all 6 joints; he had terrible arthritic pain for a couple of weeks after the first dose of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (having rheumatoid pain in all 6 joints) in a male 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (having rheumatoid pain in all 6 joints) (seriousness criterion medically significant) and ARTHRALGIA (he had terrible arthritic pain for a couple of weeks after the first dose of the vaccine.). The patient was treated with INDOMETHACIN [INDOMETACIN] for Pain, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (having rheumatoid pain in all 6 joints) and ARTHRALGIA (he had terrible arthritic pain for a couple of weeks after the first dose of the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned by reporter. The patient had terrible arthritic pain for a couple of weeks after the first dose of the vaccine. The pain kept coming back. He had to take pain medications daily, because he was having rheumatoid pain in all 6 joints. After about 5 weeks of this, the patient did not have to take pain medication anymore. The patient was taking indomethacin for the pain.  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, seriousness of the event "rheumatoid arthritis' has not been downgraded until further clarification.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, seriousness of the event "rheumatoid arthritis' has not been downgraded until further clarification.
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
Product temperature exersion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. This is a case of product temperature excursion for this 57-year-old male patient with no relevant medical history, who had no adverse reactions reported. The product temperature excursion  occurred after the patient received a dose of mRNA-1273 (Batch/lot no.- 020F21A). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a case of product temperature excursion for this 57-year-old male patient with no relevant medical history, who had no adverse reactions reported. The product temperature excursion  occurred after the patient received a dose of mRNA-1273 (Batch/lot no.- 020F21A). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Starting Oct 18, 2021, headaches daily mostly on the right side, blurred vision lasting weeks , double vision, tenderness below the ear by the jaw bone, light sensitive some days.  pain on my right brow bone lasting 2 weeks, occasion sharp pains in my head or brain,  October 27, and October 28 night sweats, tender under the left arm comes and goes.  November 4, earache,  occasion pain in the ear.  Headaches are still continuing not everyday, but a few times a week lasting half hour to hour plus. November 8, in the morning a spell of vertigo lasting hour and half to 2. December 6,  morning a spell of vertigo lasting hour.  In December blurred vision and double vision improving.
I was diagnosed with shingles 30 days after i got the 2nd covid vaccine. I had chicken pox when i was younger and all of a sudden got shingles- i had not been in contact with anyone who had the virus
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: 5 mins after the injection pt became light headed and diaphoretic and near syncope. Monitored for a total of 30 mins. Gave 16 oz of water, (2) 1 oz pieces of candy and applied an ice pack to the back of the neck. Pt left with mom and gave instructions to call back to the pharmacy or their local provider and if needed 911.
Shingles; 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 HERPES ZOSTER (Shingles) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided. No concomitant medication information was provided.
Extreme pain during period that will not go away with recommended pain killing dosage nor heating pads.
pt recvd vax inject site react which included swelling, redness & pain; react spread to back & was unable to lift arm for 2 days; 8OCT92 able to move arm but inject site react still present;
ItchiNg - symptoms resolved - No tx ment- Did not reach out to a provider TX: NonE For meds, PMoD Itching 1st day of vaccination  and resolved iN less than 24 hours
Patient Was given 3rd dose of COVID vaccine at a healthcare facility. Patient was bring down by staff to get COVID vaccine. Patient already received 2 doses of COVID vaccine but due to improper organization at facility and record keeping; pharmacist didn't realize that patient was receiving third dose. Upon further evaluation, we figured out that patient got third dose. We immediately called and informed facility staff. Patient was monitored for vitals every 2 hours. No adverse event reported until now.
About 5 am, I had symptoms and they were nausea, vomiting, extreme fatigue, chills, fever and about 3:00 pm was the peak of it. About 6:00 - 8:00 pm I started feeling better. I slept most of the day. But I did have all those symptoms all day  - I had extreme malaise. I didn't do anything. I tried to rally but couldn't do anything. My arm hurt for about 5 - 6 weeks afterwards. I woke up at about 8:00 am the following day, the 23rd it was a lot better and about noon it was done.  About 36 hours later for the majority of it.
Beyond initial flu-like symptoms, patient initially experienced bouts of light-headedness at around 10:30 a.m. the day after the 2nd shot - which was Apr 9, 2021.  After laying down for a couple of hours, the patient tried to have lunch, but experienced syncope at around 12:45 p.m.  Patient's spouse could not revive them initially, so called 9-1-1.
Received vaccine on 08/23/21, felt symptomatic (facial paralysis)  on 09/04/21, and went to Emergency Room on 09/10/21. Was diagnosed with Bell's Palsy and was treated with Prednisone.
My period mad gone from heavy to uncontrollable. 10 hour pads are full within an hour when they used to last for half the day.; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (patient).  A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiration date: unknown), via unspecified route, administered in left arm on 08Apr2021 01:00 PM (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0176, Expiration date: unknown), via unspecified route, administered in left arm on 06May2021 01:00 PM (at the age of 43-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications includes Zyrtec [CETIRIZINE HYDROCHLORIDE] and Levothyroxine both from unknown onset. On 12Apr2021, after the vaccination, the patient experienced heavy to uncontrollable menstrual bleeding, 10-hour pads were full within an hour when they used to last for half the day. Patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination. No known allergies. The outcome of the events was not recovered at the time of this report.  No follow-up attempts possible. No further information expected.
Information has been received from a Registered Nurse concerning a 25 year old female who on 15-JAN-2008 was vaccinated IM with the first dose of Gardasil (Lot #659653/01448U).  Concomitant therapy included YASMIN.  The patient experienced dizziness on the afternoon of the injection (15-JAN-2008) and on the morning of 16-JAN-2008 and 17-JAN-2008.  The patient's outcome was not reported.  The patient had an abnormal PAP test (results not reported).  Additional information has been requested.
31 y/o hospital ER nurse first time vaccine (DOV 3/12/2003) had developed nonspecific rash (probably folliculitis) 3/23/2003 resolving over next few weeks.  A biopsy done and sent was reported to me by the pt as revealing dermatitis with focal vesicles c/w vaccinia, but PCR was negative for vaccinia.  Well until 5/30/2003 when she developed syndrome characterized by acute onset of shortness of breath (woke her up from sleep), chest tightness and sternal tenderness, myalgias, lymphadenopathy, and a "red spot under her L breast.".  She was seen by MD and work up was negative (including normal EKG, CXR, and negative troponins).  Over the last two months, although her acute syndrome resolved, she has developed recurrent skin lesions and an asymptomatic swollen left ankle without history of injury.  She sought care where she has been seen twice.  Plane film of the ankle was normal.  The skin lesions are painful and rarely if ever pruritic, begin as papules, and then become vesicles.
Information has been received from a nurse concerning an 8 year old white male with no medical history or drug allergies, who on 16-JUL-2007 at 15:30 was vaccinated with his second 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 656692/0457U) in the left arm. On 17-JUL-2007 in the AM, the patient developed redness, itching, and swelling at the injection site. No medical attention was sought. No labs were performed. Subsequently, the patient recovered on 20-JUL-2007. There was no product quality complaint. Additional information has been requested.
pt recv vax 3NOV95 &  MAY96 pt mom devel chicken pox & pt devel a chicken pox like rash w/approx 20 lesions;
Reported swelling to entire (R) upper arm of injection site with redness, warm to touch and pain with movement. No rash, fever or chills.
This spontaneous report as received from a pharmacy technician refers to a 14 year old female patient. On 20-DEC-2017, the patient was vaccinated for prophylaxis with VARIVAX lot # N022978, expiration date dose 1, subcutaneous into the abdomen - a site not specifically listed as acceptable. On the same date, the patient was vaccinated with VAQTA, M-M-R II, poliovirus vaccine inactivated (unspecified) and ENGERIX-B. Nothing out of the ordinary was noted. No adverse effects were reported.
This spontaneous report as received from a registered nurse refers to incorrect product storage due to on unknown dates unknown number of patients of unknown ages and genders were vaccinated with improperly stored doses of ROTATEQ, oral (dose, lot # and expiration dates were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This one of several reports from the same source. Additional information is not expected because we cannot contact the physician.