chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm sore / pain in right arm; weakness in right arm; Today patient was in a lot of pain / worse during lateral movements or / raises her arm above her head; weakness are worse during lateral movements / raises her arm above her head; right arm was hot for 3  days; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date unknown) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Pneumonia vaccine (got last year). Concurrent medical conditions included ileo-anal pouch (J pouch) and colon cancer.   On 11th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 24th November 2020, 74 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain and weakness. On an unknown date, the patient experienced pain in arm, weakness of arms and extremities hot feeling of. On an unknown date, the outcome of the pain in arm and weakness of arms were not recovered/not resolved and the outcome of the extremities hot feeling of was recovered/resolved and the outcome of the pain and weakness were unknown.   It was unknown if the reporter considered the pain in arm, weakness of arms, extremities hot feeling of, pain and weakness to be related to Shingrix. It was unknown if the reporter considered the pain and weakness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received 1st dose of Shingrix in her right arm deltoid and a flu shot at the same time in her left arm deltoid. The patient reported right arm sore and hot for 3 days then resolved. The patient reported continued weakness and pain in right arm. The patient does arm exercise reps at the gym with 10 to 12 pound weights and did so last night. On 24th November 2020, the patient was in a lot of pain. The patient stated that the pain and weakness were worse during lateral movements or when she raises her arm above her head. The reporter did not consented to follow up.
Patient describing redness and pain at injection site more than normal reaction that has now spread to the other side of her arm. The area where the injection was given is now returning back to skin color, but the other side is still red and painful. She described it as slightly warm to the touch. Pharmacy recommended she contact her physician to have it evaluated for possible treatment.
Onset: one day after flu shot. Patient feel "drag-down", fatigue, nausea and vomting for 3 days. Vomit 1 time per day. Increase water intake and say in bed. Recovered on the 4th day.
This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a patient who received SHINGRIX. On 23rd March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema (serious criteria other: as per reporter). On an unknown date, the outcome of the localized erythema was unknown. The reporter considered the localized erythema to be probably related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient reported to the emergency room on 26th March 2018 complaining of redness on chest and redness on both arms. Reporting healthcare professional was not able to provide patient details and vaccine lot number and expiration date. The healthcare professional only reported that the patient had chest and arm redness but did not know when it started. The healthcare professional was calling on behalf of the emergency room physician and was not able to give any other details at that moment because they were only asking for a recommendation on how to treat the patient. The patient was currently in the emergency room when the healthcare professional contacted them. The emergency room physician who contacted the healthcare professional believed the reaction was caused by the SHINGRIX and would like a recommendation on whether or not it was an anaphylactic reaction or a less severe reaction.
Pt in at 0900 on 2-14-11. I gave her a PCV13 and PENTACEL. Later that evening mother calls to report child fever of 102.4.
lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples; it was like pus-like ulcers and they started to swell; was weepy and crying a lot; threw up; pale; lethargic; congestion; nose was swollen and inflamed; He (patient) was acting funny, quiet, and not himself; red welts;Initial information was received on 05-Oct-2021 regarding an unsolicited non-valid non-serious case from a Consumer via Media Information (under reference- 00798641) and transmitted to Sanofi on 05-Oct-2021.  This case involves a 11-year-old male patient who experienced He (patient) was acting funny, quiet, and not himself (Behaviour abnormal), red welts (Urticaria), was weepy and crying a lot, pale (Crying), pale (Pallor), lethargic (Lethargy), congestion (Nasal congestion), nose was swollen and inflamed (Nasal inflammation), threw up (Vomiting), lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples (Dermatitis acneiform), it was like pus-like ulcers and they started to swell (ulcer) while receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 25-Aug-2021, the patient received 0.5 ml (once)dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [lot U6821AA and expiry date not reported] via unknown route left arm for prophylactic vaccination.  On 25-Aug-2021 the patient developed He (patient) was acting funny, quiet, and not himself (Behaviour abnormal), red welts (Urticaria) (latency on the same day), on 26-Aug-2021 the patient was weepy and crying a lot, pale (Crying), pale (Pallor), lethargic (Lethargy), congestion (Nasal congestion), nose was swollen and inflamed (Nasal inflammation), threw up (Vomiting) (latency 1 days) and in Sep-2021 lesions on his elbow on the same arm (left arm) as the injection, they were like little pimples (Dermatitis acneiform), it was like pus-like ulcers and they started to swell (ulcer) (latency 2 weeks) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Other relevant tests were not reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]).  They (doctor) gave him a topical steroid. They didn't do a biopsy on the welts. They said that they would do a biopsy if they kept coming. They (lesions) left some scarring.  At the time of report the outcome of event was unknown.
vomiting; A lot of Fatigue; stomach pain; nausea; sick for about a week now; sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 25Feb2021, outcome "unknown", described as "fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 03Mar2021, outcome "unknown", described as "stomach pain"; NAUSEA (non-serious) with onset 03Mar2021, outcome "unknown", described as "nausea"; ILLNESS (non-serious) with onset 03Mar2021, outcome "unknown", described as "sick for about a week now"; VOMITING (non-serious) with onset 07Mar2021, outcome "unknown", described as "vomiting"; FATIGUE (non-serious) with onset 03Mar2021, outcome "unknown", described as "A lot of Fatigue".  Additional information: Reason for no lot number of Pfizer-BioNTech COVID-19 Vaccine was reported as Caller unwilling to complete the report. Patient gender was referred to as female during this report, but gender not verified with caller who was unwilling to complete report.  No follow-up attempts are possible. No further information is expected.
deep aching pain through fore arm, w/redness, soreness, swelling inside tissue given rs methyl pred & DPH;
6 days post-vaccination, patient began to experience itching/tingling sensation on torso and on both hands. Patient reports both hands were bright red and very itchy. Symptoms continued into days 7 and 8 post-vaccination for both arms and on the inside portion of the patient's elbows. Patient reports no blisters, shortness of breath, or symptoms elsewhere on the body.
Email received from patient on 8/18/09, followed by a phone call from her and supervisor. Described 3 mm "bump" that appeared "bruised" at inj. site, surrounded by a 1 1 /2" swollen, red area that is warm to touch. Only painful when touched now but patient required ibuprofen regularly all weekend after shot. Had fever of 102 degrees on Sat. 8/15.
Red, blistery rash that started on the stomach and is now all over the upper body. It's itchy and spreading to more areas of the upper body every day.
Chills, total body aches, entire body skin sensitivity, fuzzy brain, headache, flu symptoms, dizziness and grumbly gut set in last night. Hot and cold waves. All theses symptoms s began within 4 hours of injection on 3/29.   Today, 3/30, added Nausea to all other symptoms.  Didn't get much sleep last night. And of course,  sore shoulder at injection site.
On the day of vax, the pt experienced a temperature of 101 and a headache. the symptoms were treated with Tylenol. The most recent information received reports the symptoms as resolved.
Bump in both arms lasting PCV13 3wk. TD still not gone. Red swelling both arms-lasting 3wk. Size 3" in roundness.
Injection site itchy; Knot on the injection site; Injection site red; A spontaneous report was received from a consumer (patient), a 66 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine injection site itchy, knot on the vaccine injection site, and vaccine injection site red.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 06-FEB-2021, the patient developed knot on the vaccine injection site, which was itchy and red. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, vaccine injection site itchy, knot on the vaccine injection site, and vaccine injection site red, was not reported.; Reporter'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.
30 minutes after injection, pt experienced tiredness.  About 5 hours after injection, patient experienced severe nausea.  Woken up out of sleep at 01:30 AM with body cramps (legs, arms).  Severe soreness at injection site as well.  Pt also experienced headache and nausea today (12/18) after taking Zofran, with no effect.
The vaccine administrator used the vaccine vial again. 2 patients were involved; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine administrator used the vaccine vial again. 2 patients were involved) 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 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine administrator used the vaccine vial again. 2 patients were involved). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine administrator used the vaccine vial again. 2 patients were involved) 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.   Reporter stated that on 07-MAY-2021, a vaccine administrator punctured one Modena covid-19 vials and they put it back in the refrigerator. On 13-MAY-2021, the vaccine administrator used the vaccine vial again and 2 patients were involved.  Reporter stated that she did not have any detailed information about the patients or the vial.
OB Delivery Note:  Labor Events  Preterm labor?: No Antenatal steroids: None Antibiotics received during labor?: No Rupture of Membranes Baby:
Covid arm symtoms, several days after getting shot I developed a rash like raised area on my arm at injection site. Not very itchy just warm to the touch. About 2 inches in diameter.
Severe muscular  lower back pain  developing overnight after the shot. Unable to pick up, bend over, sit without significant discomfort.  Lasting throughout the next day. By the following morning , pain had subsided and muscles had relaxed somewhat allowing basically normal movement.
I got my first dose of Covid-19 vaccine (Pfizer) in my left arm on Sat 01/30/2021 evening from my workplace. I felt tingling sensation spreading in my left arm right after the shot. The next day, I woke up with a sore arm and the tingling had spread to the whole left side of my body including my left leg, arm, left side of torso, left side of the face and the back left side of my head. The tingling got milder over time. I can barely feel the tingling on other parts of the body except my left arm. It get numbed more easily compared to my right arm.
Patient stated that the night of the day he received the vaccine, he began experiencing  pain, redness and swelling on the injection site. Patience stated that on the following day he starting having fever it went up to 102.4. Patient sated taking Tylenol with short term relief, but the symptoms return quickly. Also patient complain of nausea and body aches. Patient was advised to go immediately tothe ER for evaluation.
Went to ER 12/13/99. C/O rash, blistery.  Referred to dermatologist.  Pt poor historian.  MD reports could be vaccine related.
1.5 hours after receiving vaccine pt began having pain from shoulder to waist on the side of body where he received the vaccination, felt nauseated and was having "hot flashes", was mildly diaphoretic with flushed skin and began erperiencing rhinorrhea.  B/P ranged 130-80 to 114-80 with HR 72-82, RR 20.  Denied dizziness or dyspnea.  Pt was observed for approximately 30 minutes, and began feeling better.  Advised to take tylenol, not ASA, for back pain, and Benadryl 25 mg and was sent home for the rest of the day from work.
Not sexually active  No period in Feburary or March 2 months missed period 1 normal period in April  no period in May Currently no period as of June 16th  OTHER:  Chest pains Sharp
Breakthrough case after two vaccines  Pfizer x2; Pfizer 3/2/21 Lot# EN6205;  Pfizer 3/23/21 Lot# EP6955
Initial report was received on 04 February 2013 from a health care professional. A 53 year-old female patient with no reported past medical history had received on 24 January 2013 a right deltoid injection of FLUZONE intradermal (lot number not reported) and one week and one day following vaccination on 01 February 2013, developed swelling right side of neck. The patient was hospitalized for evaluation (dates not reported). Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.; No adverse event; Vial was in refrigerator all the time prior to administration; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 14-Jul-2022 morning and was on refrigerator the entire time.). No concomitant medications were reported. It was reported that the patient received expired booster dose of vaccine in between 22-Jul-2022 to 02-Aug-2022. Number of doses and vials that were affected were 8 doses from 2 vials. The vial was initially stored in the refrigerator on 14-Jul-2022. The vial did not undergo any temperature excursions. The vial was in refrigerator throughout the entire time. No treatment details was reported.
Approximately 5 days after I received the Pfizer vaccine I had a budge on the back side of my left knee and was not able to fully extend it.  My left knee then began to swell. I noticeably had more joint pain in both knees and just lower body extremities.
ongoing chest pain and pressure the night of receiving 2nd dose of covid vaccine--called primary care doc and monitored throughout night, stopped next morning
Increase nerve pain and flare ups - uncontrollable  Shaking Tingling and pains in arms  Cramping  in joints unable to move fingers
This spontaneous report as received from a medical assistant refers to a 18 years female patient with no pertinent medical history and with no drug reactions or allergies. The patient was vaccinated intramuscularly with the complete series of three doses of GARDASIL (Lot # and dose not reported) on unspecified dates. No other concomitant medications. On 01-AUG-2011 a pap smear found that the patient had become infected by 13 HPV types. including types 16 and 18, at some point after the vaccinations. It was not known if the patient sought for medical attention. No treatment was given. At the time of this report the patient had not recovered. Additional information has been requested.
Pt. had flu vaccine 9/1/11 on 9/2/11 in the morning grandfather spoke with dr had a lump 1 inch in diameter at site of vaccine. Not seen in office reported over phone.
red itchy rash that spread from her chest, up her neck onto the bottom of her face and did not go; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (red itchy rash that spread from her chest, up her neck onto the bottom of her face and did not go) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced RASH PRURITIC (red itchy rash that spread from her chest, up her neck onto the bottom of her face and did not go). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Antihistamine therapy, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (red itchy rash that spread from her chest, up her neck onto the bottom of her face and did not go) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
2 weeks after injection arm began to itch at injection site,  area slightly red and warm,  began to hurt during the night enough to keep her awake, this morning 2/8/21 still red. No tenderness or hardness.
lips get swollen, raw and lips get really bad; lips get swollen, raw and lips get really bad; This is a Spontaneous report from a contactable female consumer.This consumer (patient) reported that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing verbatim: some type of allergy to some type of food product. The patient's concomitant medications were not reported. The patient experienced lips get swollen, raw and lips get really bad (lip swelling and lip disorder) on an unspecified date. Caller states that she got her shot-on Tuesday this week, 06Apr2021, beside that maybe twice a year she has some type of allergy to some type of food product, but she doesn't know what it is. She has an appointment with allergist on Thursday next week. Her lips get swollen, raw and lips get really bad. Patient was asking Is it ok to get a steroid shot or not. Caller states this was happening last week before she got the shot, clarifying this is just her life and has nothing to do with the Pfizer COVID-19 vaccine. Caller declined to proceed with safety report. Caller provided her name, phone number and date of her Pfizer COVID-19 vaccine. No further details provided. PSCC Communication: Caller states that she has been on hold for about 30 minutes, and she doesn't have time, she has to go to see her mom in a nursing home. Caller states that she didn't realize it would be such a process. Caller provided with USMI phone number and hours of operation. Caller declined website information. Caller declined to be warm transferred to USMI and hung up.  No follow-up information needed. Information on the lot/batch number cannot be obtained.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/27/2021 and 2/24/2021. Patient presented to ED on 8/14/2021 with complaints of shortness of breath. Medications administered: ascorbic acid, azithromycin, baricitinib, ceftriaxone, dexamethasone, epoprostenol, fluconazole, remdesivir, zosyn, vancomycin, and zinc. Throughout hospitalization patient continued to decompensate eventually requiring mechanical ventilation. Patient had brief episode of cardiac arrest. After family discussion, patient was taken off life support and expired on 9/9/2021.