chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible pain in her right leg all night long for about a week/her leg is sore every day; Sore to even touch/The pain does not go away since the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/her leg is sore every day) and PAIN (Sore to even touch/The pain does not go away since the vaccination) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concomitant products included DEXLANSOPRAZOLE (DEXILANT SOLUTAB) for Acid reflux (esophageal), IRON for Anaemia, BUPROPION HYDROCHLORIDE (WELLBUTRIN SR) for Antidepressant therapy, PIROXICAM (PAXIL [PIROXICAM]) for Anxiety, ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]) for Cholesterol, LOSARTAN for Hypertension, TRAZODONE for Sleep disorder.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/her leg is sore every day) and PAIN (Sore to even touch/The pain does not go away since the vaccination). At the time of the report, PAIN IN EXTREMITY (Terrible pain in her right leg all night long for about a week/her leg is sore every day) and PAIN (Sore to even touch/The pain does not go away since the vaccination) had not resolved.            she does not know which dose quantity was applied for those 3 doses.  she does not have any allergies.she did not have any acute or chronic illnesses.  She did not tested positive for Covid-19 and did not receive any other vaccine 1 month prior to Moderna.  she did not have any acute or chronic illnesses.  She never experienced a similar event on the past.She went to see her Dr at the facility in contact 3 before getting the Booster shot because she did not want to receive Moderna's, but HCP told her that if she got the Moderna primary series she had to receive the Moderna booster as well.  No treatment medication was reported.   This case was linked to MOD-2022-485263, MOD-2022-485309.
Swelling of legs much worse, red spots on top of feet that leaked blood, numbness, burning pain in feet at toes, ball of foot ankle of right leg. Then pain in calves and behind knees.
A dose of Moderna 0.5ml was given IM vs Moderna 0.25 ml for booster
Can the second does cause low fever reading; How long until muscle aches subside; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown.   It was unknown if the reporter considered the fever and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After receiving the 2nd dose the patient experienced low fever muscle aches.
Three days post vax,  the pt experienced swelling, redness, and pain, from elbow to shoulder. Treated with Ibuprofen and ice for swelling. Incident resolved by the time it was reported.
Experienced moderate headache and associated nausea 15 minutes after vaccination. Symtpom resolved in 30 minutes wuth acetaminophen and Compazine 5 mg orally x1
pt recv vax 19JUN96 & had high pitched screaming, t102;pt seen by MD;
CLIENT GIVEN PED/ADOLESCENT DOSE OF HEPATITIS A VACCINE INSTEAD OF ADULT DOSE. DOSES WERE IN PAPER GOLD ENVELOPE  WITH "ADOLESCENT"SHORTENED TO ADOL AND NURSE READ IT AS ADULT. SYRINGES THEMSELVES DO NOT SPECIFY ADULT OR PEDIATRIC/ADOLESCENT. WHILE CHARTING THE MIX UP WAS DISCOVERED. CALLED SUPERVISOR AND CLIENT AND EXPLAINED. CLIENT AGREED TO COME UP TO HEALTH DEPT THE NEXT DAY FOR ANOTHER DOSE (ADULT) AS IT WAS TOO LATE FOR THEM TO COME UP THAT DAY BY THE TIME THIS RN CONTACTED THEM. THEY REPORTED THEIR PHONE HAD BEEN SHUT OFF. THEY DID NOT SHOW UP OR ANSWER THE PHONE THE NEXT DAY BUT CAME TO FLU CLINIC ON 10-30-2020 AND THIS RN HAD PORPER ADULT DOSE OF HEPATITIS A VACCINE READY AND ADMINISTERED TO CLIENT. CLIENT TOL WELL.
pt noted erythema w/induration, tenderness & warmth to touch @ inj site; by the next day p/vax;erythema progressed to 3" diameter w/some c/o pruritus on 11/19/99 2 site;
dizzy; I feel achy; leg cramps; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PAIN (I feel achy), MUSCLE SPASMS (leg cramps) and NAUSEA (nauseous) 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-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced DIZZINESS (dizzy), PAIN (I feel achy), MUSCLE SPASMS (leg cramps) and NAUSEA (nauseous). At the time of the report, DIZZINESS (dizzy), PAIN (I feel achy), MUSCLE SPASMS (leg cramps) and NAUSEA (nauseous) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Dose 2: 3/17/21: I was wearing a smart watch and received over 10 high heart rate alerts that day even though I was laying on the couch all day as I was having body aches and chills and a fever. My heart also felt like I was having palpitations . The symptoms only last 24 hours.   Dose 3: 12/2021: The third dose I was able to get off the couch but I was still receiving high heart rate alerts throughout the day. I was having more fluttering in my chest. The symptoms this time last 3 days and I was also having chest tightness and shortness of breath.
She developed several markedly tender, swollen, red areas both at and adjacent to the area the pneumovax was given in the upper arm.  First noted the next morning.  Denies itching, other rash, oral/mucosal lesions, resp symptoms, fever, joint pain. On exam, there are 5 distinct oval to round areas of redness, warmth, tenderness, induration on left upper arm.  (see physical exam notes below) Treated with naproxen and cold compresses, Benadryl at bedtime. Plan to recheck next clinic in 4 days. The patient did not recall prior pneumovax but review of the state vaccine registry, shows she had a  pneumovax on 1/7/11. Physical exam notes: The spot where the injection was given is present over the left deltoid. There is an 8x5cm area of mild redness, warmth, mild induration and moderate tenderness around that. There is no fluctuance or streaking. Medial to that she has two similar areas (but more red and tender) approx 1.5x2cm; inferomedial to that a similar 3x2cm area and inferomedial to that a 7x4cm area. The areas are adjacent rather than confluent. There is no central clearing.  There are no vesicles, papules or pustules.  Has FROM.  CMS intact distally.  Mild, tender left axillary lymphadenopathy without erythema.  The right deltoid where the Shingrix was given is mildly tender but there is no erythema, rash or induration.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. The patient's  medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored GARDASIL 9 lot # M003659, with expiration date 20-SEP-2017, (dose and route of administration not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Head ache; arm pain; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL92962, expiration date not reported), via an unspecified route of administration, administered on the left arm on 27Jan2021 12:15 (at the age of 55-years-old) at a single dose for COVID-19 immunisation.  The patient's medical history was not reported. Concomitant medication included levothyroxine (manufacturer unknown) taken for an unspecified indication.  The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Health Clinic. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced head ache and arm pain on 27Jan2021 16:45. Events were assessed as non-serious. Treatment was not received for the events.The outcome of events was recovering.
Patient was given MMR, Varicella and Hepatitis A vaccines on 7-28-08. On 8-4-08 he developed weakness, ataxia, excessive abnormal crying and fever. Also had fever. Symptoms lasted about 48 hours. He is better today but still slightly ataxic.
Pain in upper left arm. Restricted range of motion.  Difficulty sleeping as I bend my arm. Have to find correct spot to bend it!  PT Ongoing
pt seen in ER for injuries to face & chest exp @ work;pt was given TD vax & devel 3" warm, swollen, red area @ inj site, w/neck & arm stiffness & pain & h/a about 1wk;
Patient was given an injectable Typhoid vaccine which was not needed as the patient had an oral Typhoid vaccine 5-1-2019 and this vaccine was still valid.
I had a fever, which was bad, a sinus infection and a little bit of nausea.
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included History: Patient never had any problems when he/she take immunization shots, no flu, no phenomenon shorts, not even the covid vaccination..   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The patient was treated with paracetamol (Tylenol). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 13-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she never had any problems when he/she take immunization shots, no flu, no phenomenon shorts, not even the covid vaccination. The patient states that he/she so grateful he/she never get anything but a little sore arm, as soon as he/she went home and take Tylenol, he/she never let his/her arm start to hurt before he/she take something. Follow up was not possible, as no contact details were available. This case was linked with case US2023AMR097175 with same reporter.; Sender's Comments:  US-GSK-US2023AMR097175:same reporter
4 hrs p/vax pt very drowsy & sleeping; severe shaking 10-15 mins then laid & stared until fell asleep, t102, screaming ?, rt thigh swollen, approx 2" diameter erythema; 16DEC MD visit, t102 no other apparent prob;
patient has painful shoulder, cant raise left arm above shoulder level,  believes it is adhesive capsulitis
Patient received injection in the AM. In the afternoon she had difficulty moving/lifting her left arm and slight neck pain. Reports she was fatigued and had a small rash at injection site. Symptoms resolved the following day with residual soreness and small rash on her arm only. Patients symptoms were reported via telephone call by her.
Information has been received from a physician via questionnaire concerning a 14 year old student female patient who on 04-FEB-2013 was vaccinated with a dose of GARDASIL, IM, lot # H012973, Exp date, March 2015. On 05-FEB-2013, the patient experienced an episode of memory loss after receiving the GARDASIL dose on 04-FEB-2013. She had of memory loss that lasted 15 sec and almost for about 1 and a half week till approximately 15-FEB-2013. The physician reported that she would be at softball field in Gym in class and not know she was it resolved in its own and currently there is no complaints. Additional information has been requested.
felt of balance and like they could fall over; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (felt of balance and like they could fall over) and DIZZINESS (Felt dizzy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Mezotrace for an unknown indication.   On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (felt of balance and like they could fall over) and DIZZINESS (Felt dizzy). At the time of the report, BALANCE DISORDER (felt of balance and like they could fall over) and DIZZINESS (Felt dizzy) outcome was unknown.            No treatment medication was provided.
Patient received COVID19 vaccine at clinic at 11:52 am,  discharge post treatment stable.  Got home around 2:30 pm went to bed.  He usually got tired post dialysis. He did not wake up at 6 pm.  His wife went check on him. found patient cold and unresponsive.  911 pulseless PEA. ER Medical hospital. Pronounced death at 7:40 pm
Severe tinnitus in left ear. Initial occurrence after 2nd dose in Jan. 2021. Had diminished significantly. Recurred almost immediately after "booster" (3rd) dose given.
patietn says she had a seizure for roughly 1 minute.  It is now 2 hours later and there are no lingering side effects. PT is at baseline
Only adjuvant administered; Only adjuvant administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) (batch number FA95N, expiry date 28th July 2023) and (batch number 052JX, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter stated that a 2 antigen ( powder) was left in the Shingrix box and the reporter believes that  2 patient out of the 10 patients received only the adjuvant portion of the Shingrix.  Hcp provided Lot number for both the powders that was left in the box: lot#FA95N, expiration date 28th July 2023 (Same lot# and expiration date for both powder).  Liquid administered was lot number 052JX (same for both liquid no expiration available). The reporter was planning to revaccinate all 10 of them because she was unsure who got them. The reporter did not had any information to provide on the patients. The reporter give consent to follow up. This case is linked to the case US2022AMR153035, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR153035:Original Case : US2022152231
approximately 10 days post vaccine shot, onset of headaches and tiredness for two days. On the 12th day, I ended up with facial droop and being rushed to the emergency room. Ct. scan and subsequent mri ruled out a stroke and diagnosis after spending two days at hospital was Bells Palsey.
Client received her second dose of the Pfizer Covid-19 Vaccine (Lot # ER8735 Exp. 07/2021) at 14:07 at Agency. The client, a 47 year old female, came into Agency at approximately 15:00 with a chief complaint of a localized rash to her right arm. Two EMTs and one RN responded. The client drove herself to Agency after driving home and walked in alert and tracking with her eyes with no apparent distress. The client was alert and oriented to person, place, time and event and airway, breathing and circulation were intact. The client had a minor localized rash on her right arm described "numbness" on her lips. She also stated that the symptoms started while she was driving home, approximately 30 minutes after injection. However, EMTs did not notice any swelling, discoloration and/or other signs and symptoms of allergic reaction on her lips. The client denied any allergies or medications. The client stated that she had no reactions to the first dose and there were no signs and symptoms of allergic reaction on her right arm where she received the vaccine. The client agreed to stay an additional 30 minutes for observation and vital signs were taken every 5 minutes. Vital signs are as follows: 1500 blood pressure 128/90 pulse 84 temperature 98.3 O2 100% skins normal. 1505 BP 128/80 P 68 Temp 98.3O2 100% S normal. 1510 BP 128/80 P 71 O2 95% Temp 98.2 S normal. After the client's vital signs were taken she stated that she was feeling better and decided to depart Agency after 10 minutes of observation. The client was given all relevant information regarding normal signs and symptoms as a result of the Pfizer vaccine and was informed to call ED in the event of severe allergic reaction. RN and EMT educated client about the possible signs of an allergic reaction and provided her with the vaccine fact sheet. Client verbalized that she would ?go to the hospital? if the symptoms of an allergic reaction presented. Client departed AGENCY at approximately 1510 in positive disposition with steady gait.
Extreme headache, chills body aches, nausea, fatigue  Developed more nausea and a rash on day 3
Information has been received on 27-OCT-2016 from a pharmacist regarding a 60 year old female with morphine related reactions. Patient received ZOSTAVAX (lot# L028283, expiration date 28-OCT-2016) subcutaneous in the left arm on 25-OCT-2016. "A day later" patient noticed redness in an elongated shape near the injection site. Yesterday, she noticed that the "redness got bigger and elongation is now 2-3 inches long and itches". Patient sought medical attention and call pharmacist. Patient received unspecified treatment for her adverse event. Patient's present status was not recovered. No additional information. Additional information has been requested.
Cried for 7 hours after shots, did not want to be touched. Temperature 98.7F, emesis x1, decreased POS. FHx: pertussis reaction in family.
rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear; This is a spontaneous report from a contactable physician. A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date  not reported), via an unspecified route of administration on 22Dec2020 14:00 at a single dose on Arm Left for COVID-19 immunization. Medical history included none. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 23Dec2020 21:00, the patient experienced Rash which started at site of injection, appeared to be urticaria, migratory to b/l legs, arms, back, neck. Started to appear on face and ear. Treatment was received for the adverse event which included Benadryl 50mg. The outcome of the events at the time of last observation was recovered/resolved on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered as non-serious.  Information on the lot/batch number has been requested.
hospitalized with a 3 day history of cough and fatigue with shortness of breath,
Narrative: Pt received Covid-19 vaccine dose #1 1/21/21 - reported no ADEs until 2/2/21 where Pt developed hypotension (active med: midodrine- no antihypertensives) and confusion (Pt with baseline dementia). Pt also was febrile at home with a cough. Brought to ED on 2/2/21 for evaluation of confusion and low blood pressure. Pt's family members noticed BP was low (70s) and Pt was acting confused. Pt had been running a fever starting 2/2/2021. Son denied any other symptoms. Pt is currently hospitalized at hospital where he is being treated for COVID + Pneumonia as well as determination of etiology of hypotension (ruling out adrenal insufficiency).
?Pfizer-BioNTech COVID-19 Vaccine EUA?  swollen joints in both hands and feet fuzzy head feeling  unable to sleep 36 hrs after injection
Mood swings are bad; Fatigue; Bleeding heavily; I started my cycle 10Jan and here it is 31Jan and I am still bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Jan2022, outcome "not recovered", described as "I started my cycle 10Jan and here it is 31Jan and I am still bleeding"; AFFECTIVE DISORDER (non-serious), outcome "unknown", described as "Mood swings are bad"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Bleeding heavily".  Additional information: Patient was spoken to a half dozen women in my immediate area who all say they went through the same thing after getting the vaccine. One woman bled for 3 months and had to have a blood transfusion.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 22-FEB-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.