chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she did gain some weight; can not get around like she used to; can not get around like she used to; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 80-years-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 80 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "blood thinner" (ongoing); "flu" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for blood disorder, start date: Aug2020. Past drug history included: Aspirin; Warfarin. Vaccination history included: Flu shot, administration date: Aug2020, for flu, reaction(s): "legs started swelling". The following information was reported: DYSKINESIA (non-serious) with onset Mar2021, outcome "not recovered", WEIGHT INCREASED (non-serious), outcome "unknown" and all described as "she did gain some weight"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "cannot get around like she used to". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller was a consumer that was calling about the Covid-19 Vaccine and reported that she had the first dose of the vaccine in February and ever since she had it, she could not get around like she used to. She had trouble getting around. She said that she has never had the flu in her life. She said that her doctors were not listening to her. She also said that she took the Pfizer blood thinner, Eliquis, and said that it worked. It was a miracle. Weight: She stated that she did gain some weight. She said that she got a flu shot and her legs started swelling and that was a year ago in August and that was when she started having to take Eliquis. She said that she called her doctor and told them that one of her legs was bigger than the other. It was freezing cold when she went and got the Covid-19 vaccine. It was in Feb2021. She said that she got sick from the first flu shot that she took a couple of years ago. She said that it was just so distressing that she could not get around. She was not able to get around after a couple of weeks after receiving the vaccine. She does not want to get the other dose of the vaccine because she was afraid it will get worse. She clarified that she only had the flu once at 21 years old. She said that maybe she should not have gotten the vaccine. She stated that it was at the end of Feb2021, when she received her Covid-19 vaccine. She said that she used to be able to take aspirin, but she cannot take it anymore. She said that she knows that Aspirin can help to get around. No further details were provided. She said that she was thankful she was not on Warfarin because we have to watch our diet and have to go to the doctor all of the time to get blood drawn. No further details were provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness upon movement of head which subsides when stops moving head. Denies nausea, vomiting, diarrhea or blurred vision.
5 minutes after receiving the vaccine I had a rapid heart rate, shortness of breath, tight chest, very jittery. I reported to EMT on site he said I was fine was probably due to not eating anything before vaccine. Left, got something to eat felt better. Arm sorness after injection that lasted 4 days, very cold feeling for 4 days after vaccine. Developed brain fog that still has not cleared up since vaccination. On 1/12/2021 I woke up for work, as I was combing my hair I noticed the lymph nodes on back of skull and neck were raised and very swollen. Started developing vision problems and stabbing pains in my eye. Immediatly called my PCP, he had me come in thought it was shingles and gave me Valtrex to take. This did nothing for me, no rash, no symptoms ever appeared. I called again and he had me go in for an MRI and CT of my neck/head. I still have motor skill problems, dropping things, brain confusion, lymph nodes all over my body are swollen at random times, I have now developed muscle spasms in my legs and feet. Was sent to a Neurologist as they thought I might have a MS lesion after brain MRI. Still ongoing treatment for that issue. I have had no energy at all since this vaccine, having difficulty talking to patients at work, still get dislexic problems, symptoms seem to get worse with higher levels of stress.
Patient has soreness on arm at injection site and woke up feeling weak and tired. They took tylenol to help with symptoms. Even though these adverse events are generally seen after receiving vaccine, we are reporting these because the vaccine vial was at room temperature for about 31 hours when the patient received their vaccine. That is still within Pfizer's recommended temperature of 36 hours at room temperature.
I first noticed a cough and was hoping it was just a cough. It kind of got worse or worse. By the next day I was getting chills and my temperature was 100.5 degrees. I did a COVID-19 At Home Test and it was positive. I contacted a place called clinic and they asked a lot of questions about symptoms and my test and my health information. She called some Paxlovid for me.
Same day as vax, pt experienced fever, increased sleeping, lethargy, almost dazed, increasing to point of hospitalization.
After Covid shot Metallic taste in my mouth Injection was on left side Extreme paid on left side of body Body aches Skin painful Scalp painful Throbbing headache Fatigue  Milk production low on left side Milk difficult to let down Left foot painful at break site Jaw painful-clicking  Neck and back very sore especially left sd Nausea  Painful pumping  Sweating at night Irritability
Generalized weakness, nonproductive cough, mild bifrontal headache. Symptom onset 1/1/22.
Blood pressure high; High heart rate; A spontaneous report was received from a reporter, concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experience high blood pressure and heart rate.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the reporter stated that his step-mother who received the vaccine, experienced an adverse side effect of high blood pressure and heart rate which lasted about 2 hours. The reported mentioned that the patient was being monitored in the hospital where she received the vaccine. No treatment was information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of events, high blood pressure and heart rate, were unknown.  The Follow up information was received on 11 Mar 2021. No new information was provided.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced the non-serious unlisted events of Hypertension and Heart rate increased. The events occurred on unknown date after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based  on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas; Breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas; This literature case, derived from a full-text article, was received on 02NOV2022.  Literature citation:   A five-month-old "breastfed infant acquired a vaccinia lesion after her mother developed vaccinia lesions on both areolas" (PT: Vaccinia virus infection and Infection transmission via personal contact) who apparently developed the infection from the father who had been vaccinated with ACAM2000 (smallpox vaccine, live).  Case report: A five-month-old, breastfed infant acquired a vaccinia lesion on her upper lip, tongue, and cheek after her mother developed vaccinia lesions on both areolas. The mother's infection apparently originated from the father who had been vaccinated about 10 days prior.  Author's comment: Persons who received smallpox vaccine during pregnancy or breastfeeding should avoid breastfeeding and handling any baby for at least 3-4 weeks until the vaccination scab has separated from the vaccination site. The breasts can be pumped to maintain the milk supply, but the milk should be discarded. Infants are at high risk of developing serious complications from live vaccinia smallpox vaccination.   Smallpox (vaccinia) vaccine should not be used during nursing.  Based on the available information in the article, two individual case safety reports 22000256 (baby) and 22000257 (mother) were created and cross-linked in the database.  Company comment:  A breastfed infant acquired a vaccinia lesion after mother developed vaccinia lesions on both areolas from close contact with recently vaccinated husband (Secondary transmission).  No additional medical history was captured. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection through close contact. Considering the case information, the role of ACAM2000 cannot be ruled out and the causality of vaccinia virus infection and infection transmission via personal contact is assessed as possible. According to literature infants are at low risk of harm while nursing.  However, the case is considered serious due to medical significance of vaccinia virus infection.; Sender's Comments: A breastfed infant acquired a vaccinia lesion after mother developed vaccinia lesions on both areolas from close contact with recently vaccinated husband (Secondary transmission).  No additional medical history was captured. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection through close contact. Considering the case information, the role of ACAM2000 cannot be ruled out and the causality of vaccinia virus infection and infection transmission via personal contact is assessed as possible. According to literature infants are at low risk of harm while nursing.  However, the case is considered serious due to medical significance of vaccinia virus infection.
Shaking hand; Cold and crummy hand; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   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.
Arthralgia, arthralgia 2 days post vaccine and persist>10 days Narrative:
Patient reported numbness to upper lip and itching to her back. Pt observed by EMS personnel, vital signs were stable; Pt. released after 30 min.
No additional AE/no PQC; ROTATEQ  was administered after temperature excursion.; This spontaneous report was received from medical assistant and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-AUG-2023, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, first dose, lot #1968393, expiration date: 24-MAY-2024, administered orally for prophylaxis (strength was not provided) following a temperature excursion of 8.9 degree Celsius (C) for 12 hours 20 minutes o seconds and 9.4 C for 8 hours 20 minutes and 0 seconds, it was stated that no previous temperature excision occurred. No additional adverse event was reported.
Gave client flu vaccine as a part of the school flu project. Mom works at school. Approximately 30 minutes after administering vaccine mom brought client back to nurse arm swollen at vaccination site. About the size of a lemon. Applied ice pack and gave BENADRYL 12.5 mg. No further problems reported.
VACCINATED MARCH 31ST, headache appeared on Saturday April 3rd, associated to minor nose bleeds and blood tinged sputum.
24 hrs post/vax, c/o itchy rash over body, sore throat, ears hurt & swollen neck glands. Took Benadryl. Seen by Dr 12/12/99, kept on Benadryl. On 12/13, pt went to PMD who started pt on Prednisone.
Vaccine was administered at 1:20 PM. Checked on patient at 130  PM and found patient diaphoretic and pale. Patient stated he had eaten about an hour ago. Blood pressure 60/40. Gave patient some water and a cool rag around neck. Also, gave patient a soft drink. Rechecked BP at 1:35 was 80/50, BP at 1:45 was 100/60. BP was 110/65 at 1:50. Patient no longer pale or diaphoretic. No complaints. Pt asked to leave clinic. Encouraged patient to go to ED if symptoms return. Verbalized understanding .Left around 1:55PM
PT GOT FEVER, CHILLS, BODY PAIN NORMAL AFTER VACCINES SYMPTOMS BUT PT RECEIVED IT TWICE BY ERROR IN 3 MONTHS DURATION
This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX) and oxycodone. On 30th October 2021, the patient received the 2nd dose of Shingrix. On 30th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced stomach pain and headache. The patient was treated with prednisone. On an unknown date, the outcome of the stomach pain and headache were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the stomach pain and headache to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix and had been experiencing headaches, and severe stomach aches. The patient received the dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule. The patient had an electronic visit for his (primary care physician) PCP on 8th December 2021, as a result and was prescribed prednisone. The reporter did not consent to follow-up. The reporter did not consent to health care professional contact, but did consent to personal contact.; Sender's Comments: US-GLAXOSMITHKLINE US2021AMR253640:same reporter.
feverish; slight headache; left arm where the injection was given, felt hot and very sore (felt like heat was radiating); left arm where the injection was given, felt hot and very sore (felt like heat was radiating); This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 02Apr2021 (at the age of 62 years old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included AFIB (atrial fibrillation) from Dec2018 to an unknown date, mitral valve replacement, known allergies to milk, lactose allergy, and allergies. The patient was not pregnant at the time of the events. Concomitant medications included metoprolol tartrate taken for an unspecified indication, start and stop date were not reported, rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITIN) taken for hypersensitivity, start and stop date were not reported; and acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. The patient previously took the first dose of BNT162B2 on 09Mar2021 for COVID-19 immunisation and experienced metal taste in mouth, soreness at injection, tired, and on the outside of my left arm a pain shot down my arm all the way down my pinky finger.  On 02Apr2021, the patient experienced left arm where the injection was given, felt hot and very sore (felt like heat was radiating). On 03Apr2021, the patient experienced feverish and slight headache. No treatment was received for the events. The outcome of the event vaccination site pain was not recovered, and outcome of other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed lymadenopathy and vasculitis in my right breast as discovered on an MRI.  I had a breast biopsy (inconclusive), many blood tests, consults with a rheumatologist and orthopedist and additional radiographic studies.
Left arm. Looks like a hive around shot area. Itchy and feels very firm. Not worried but wanted to provide info in case others had same reaction.
The patient called on 8/17/21 and said that night or the next morning she had a left swollen lymph node in her neck and that it had stayed swollen since 8/10/21. She said she had no other symptoms. She was concerned it may be due to the vaccine. I recommended that she be checked by her PCP or a walk in office.
pt recv vax & exp inj site soreness w/bruising & itchiness ;pt also c/o of area being sensitive to touch;MD felt site not infected;pt has recv flu vax in past w/no rxn;
Pt received DTAP and Comvax in left thigh on 07/09/03.  Pt received IPV on 07/09/03 in right thigh.  ON 07/11, pt examined by MD and found to have on left thigh, 2 injection sites.  The lower distal site has a large indurated area about the size of a quarter with surrounding erythema in the SC area approximately 6cm at it's largest diameter.  Warm to touch, non tender.  Treatment: Keflex 200mg three times a day for 7 days.
I received my 1st Novavax vaccine at 3:30 on Saturday Nov 4th.  On Sunday Nov 5th I woke up with a migraine and heart rate 120-140 beats per min until 5:30 pm.  At 5:30 heart rate was 90-100.  At 9 pm rate went to 76.
Experienced fever (102.0 degrees F) and  soreness at injection site (left deltoid region) 24 hours after receiving injection.  Had stomach discomfort 2 days after receiving injection.
Patient received a dose of Moderna covid vaccine approximately 3 months after completing a covid vaccine series with the Pfizer product (1/12/21, 2/2/21).  The Moderna vaccination was also 90 days after the patient received treatment with bamlanivimab (1/17/21).  This "extra" vaccination was done at the behest of the patient's conservator.   No adverse effects noted by patient's doctor.
pt stated that she was good with just a little headache and some nausea that lasted about 30 hours.  pt states that her symptoms have subsided.
Patient came into the store today to let me know of the side effects he experienced. Patient chose not to wait the recommended 15 min following his vaccine and instead went into his parked vehicle.  He immediately experienced visual disturbances, extreme sweating, light headedness.  Symptoms continued even with his A/C on high.  He did not fill he could return into our store and waited @ 20minutes till he felt better.  The remainder of the day he did not feel right and may have had issues concentrating at a schedule trust fund appt who he had with his wife.  Symptoms eventually subsided.
heart inflammation, pericardinal effusion, inflammation of the heart, fluid drained from heart. on January 7th,2022. I am a healthy person, eat correctly, exercise, into fitness, in martial arts, i had a  healthy heart, and no health problems at all. since the vaccines, i have been getting colds, and cough. off and on. i never had covid at all either.  I had a procedure on January 7th 2022 where fluid collected around my heart and right lung. i went to see the blood  doctor, a rhuematologist and a cardiologist, and my regular doctor, none of them can figure out why this happened to me.
"COVID  Arm":  2/19/2021 had swelling & itching at injection site.  2/21/2021 injection site became red.  Given hydrocortisone cream for itching.  APRN advised it was ok for patient to receive second dose.
LESS THAN 48 HOURS AFTER IMMUNIZATION, PT DEVELOPED BODY ACHES, SORE THROAT AND NAUSEA.
Fever and chills at 9pm, at 2am 01Oct2015 walked to bathroom to urinate and passed out collapsing to floor, passed out again two minutes later returning to bed, in both cases regained consciousness immediately, in second case began to perspire freely immediately afterwards, slept until 7am and woke with no fever, sweats, or other problems.
Pt has knot on right leg where PEDIARIX vaccine was given and has been there for almost 2 weeks. Pts mother has tried alternating ice and heat with no relief.
leaky syringe during injection of vaccine; Poor quality device used; This spontaneous report as received from a pharmacist and refers to a female patient of an unknown age. No information regarding patient's concurrent conditions, pertinent medical history and concomitant therapies was provided.   On 17-AUG-2020, while the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 ml (route of administration, indication were not provided)  (lot # S027979, expiration date: 30-MAY-2021), prefilled syringe, a leaky syringe occurred. It was reported that the leaking occurred between the syringe hub/luer lock and syringe needle, while giving the injection (and also after the injection was given). The syringe was disposed of in a sharps container and not available to be returned. The pharmacist asked, if there was any recommendation on revaccination and/or if the patient should have titres tested to see if another dose is needed. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Moderna COVID-19 Vaccine EUA Diarrhea, +2F fever, chills, headache, open ear canal, queezy stomach, tired started about 24 hours after vaccination  Subsiding 48 hours after except still quite tired, loose stool.
sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm) and HEADACHE had resolved.            No concomitant drug information was provided. No treatment information was provided.