chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Slept a lot; bone pain; No appetite; wrists and hands/fingers; Felt ill; muscle pain; slight fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERSOMNIA (Slept a lot), BONE PAIN (bone pain), DECREASED APPETITE (No appetite) and PAIN (wrists and hands/fingers) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu Vaccine. Concurrent medical conditions included Hypertension, Hyperthyroidism (Post ablative hyperthyroidism), Osteoarthritis (experienced much more pain than usual) since 2019, Osteoporosis (experienced much more pain than usual) since 2019 and Reactive airways disease. Concomitant products included METOPROLOL, PRAVASTATIN, LEVOTHYROXINE and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) for an unknown indication.   On 26-Feb-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021 at 3:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021 at 11:20 AM, the patient experienced PAIN IN EXTREMITY (Sore arm), HYPERSOMNIA (Slept a lot), BONE PAIN (bone pain), DECREASED APPETITE (No appetite), PAIN (wrists and hands/fingers), MALAISE (Felt ill), MYALGIA (muscle pain), PYREXIA (slight fever) and CHILLS (Chills). The patient was treated with NAPROXEN at an unspecified dose and frequency. On 29-Mar-2021, PAIN IN EXTREMITY (Sore arm), HYPERSOMNIA (Slept a lot), BONE PAIN (bone pain), DECREASED APPETITE (No appetite), PAIN (wrists and hands/fingers), MALAISE (Felt ill), MYALGIA (muscle pain), PYREXIA (slight fever) and CHILLS (Chills) had resolved.
3 year old was given a dose of PENTACEL and IPOL (extra dose of IPOL) with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 3 years old male patient who experienced 3 year old was given a dose of pentacel IPV (vero) [IPOL] (extra dose of ipol) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (MRC 5), tetanus vaccine toxoid (pentacel) and pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for prophylactic vaccination and hepatitis A vaccine for Prophylactic vaccination.  On 25-Aug-2023, the patient received 0.5 ml dose 3 of suspect IPV (VERO) Suspension for injection (lot W1A101M and expiration date- 10-Feb-2025) via subcutaneous route in the right thigh (strength: not provided) for Immunization (extra dose administered) (latency- same day).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is one case out of a cumulative total of 16 cases received during the surveillance period from 01 January 2010 to 22 March 2011. Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray finding were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to a laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protoccol. Documents held by sender: None.
Information has been received from a Merck Pregnancy Registry for GARDASIL from a registered nurse concerning an 18 year old female, with no drug reactions or allergies, with a history of anaemia, who on 23-AUG-2007 was vaccinated, intramuscularly, with the first 0.5 mL dose of GARDASIL.  Concomitant therapy included prenatal vitamins (unspecified).  The patient was subsequently determined to be pregnant, and had an exam in the office.  The patient had an abdominal ultrasound.  Her last menstrual period was 24-JUN-2007 and estimated delivery date was 30-MAR-2008.  No problems were reported.  No further details were available.  Follow up phone call information was received from a nurse who reported that the patient delivered a normal, healthy baby in March 2008.  The baby was checked by a pediatrician and everything was fine.  No anomalies were found.  No additional information is expected.
Severe tinnitus the next day following the first dose of the vaccine.  It worsened after the second dose.  Constant, high pitched ringing bilateral ears. Symptoms have continued without cease.
Worsened sharp headaches; jaw pain; This is a spontaneous report from a contactable healthcare professional (patient). A 32 years old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246) intramuscular, in left arm, on 15Jan2021 at 09:30, for COVID-19 immunisation. The first dose of vaccine was given on 23Dec2020 at 17:30, intramuscular, in left arm (lot EJ1685), at the age of 31 years, experiencing right ear infection and right sided headaches 2 weeks after this first dose. No other vaccine was given in four weeks. Medical history included asthma, known allergies: a yellow mushroom from overwatering house plants, PCOS, eczema. The patient had no COVID prior vaccination and had not been tested for COVID post vaccination. Concomitant medication included topical triamcinolone acetonide 0.1% cream. On an unspecified date in 2021 the patient experienced worsened sharp headaches with jaw pain. Headaches became mild and jaw pain relieved when she removed ear wax. The final events outcome was unknown.
This case was reported by a healthcare professional and described the occurrence of low seroconversion to combination Hep A/Hep B vaccine in a 46-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 11 November 2010, 11 June 2010 and 11 May 2010 the subject received 3rd dose, 2nd dose and 1st dose of TWINRIX to complete the three dose series. Titers were drawn on 11 December 2010 and were found to be negative. The subject experienced low seroconversion to combination Hep A/Hep B vaccine. No additional details were provided. The nurse did not have the lot numbers for the vaccines administered. It was reported that the subject may have received a hepatitis series in the past (2007). Titers drawn in April 2010 prior to TWINRIX administration were negative.
Pt verbalized feeling dizziness and nausea. Escorted to cot area. Encouraged to stay an additional 15 minutes. Given Water. Vitals WNL. No other adverse reactions. After 15 minutes, patient stated he was fine and exited.
Immediate soreness in right arm and continued soreness especially when lifting arm above head. Icing and heat have been used as well as Ibuprofen with not much relief. The shot was given relatively high in the deltoid muscle.
Patient states that she was fine after initially receiving vaccine. Only experienced a sore arm for a couple days. 8 days after receiving vaccination patient states that her arm begin to itch. later on a rash and blister appeared on upper arm. Patient states that "she doesn't know if the blister is at the site of injection but does confirm that blister is on arm. Patient states that once rash and blister appeared that she started to experience a sore arm again. Patient also reports that arm is red from shoulder to elbow.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were unknown. On 08-FEB-2018, the patient was vaccinated with an expired dose of PROQUAD (strength, route, dose and frequency were not reported) (lot # M035690, expiration date: 06-FEB-2018) for prophylaxis. The reporter stated that PROQUAD did not have any temperature excursions prior to administration. No adverse event (reported as symptoms) were reported. There was no product quality complaint (PQC) reported.
I got the first vaccination on 1-12-21.  On 1-23-21 I started noticing red splotches on my legs and stomach. I went to urgent care on 1-26-21. They did a blood test. Results were normal. They referred me to a dermatologist. They did a biopsy. Biopsy came back as leukocytoclastic vasculitis. I was put on prednisone for 3 weeks.  It seemed to keep the flare up down. They took me off the steroids and I flared up all over my body. Red splotches and blood blisters from my feet to my neck.  I'm now back on prednisone. They have no answers to why I'm breaking out. The only thing that has changed was me getting the first vaccine. I have not got the second and do not plan to, until they got answers for the breakout.
This spontaneous report as received from a medical assistant refers to a 14 month old female patient with no drug reactions or allergies and with no medical history. No concomitant medications were reported. On an unspecified date in February 2015, the patient was vaccinated with a dose of MMR II, (dose, route of administration, injection site, lot number and expiration date were not reported). It was reported that after the vaccination the patient developed a 1 inch red "hive-like" bump near the injection site (on an unspecified date in February 2015). According to the reporting medical assistant, the child was observed for 20 minutes and the red bump diminished during that time, but it did not disappear completely by the time the patient left the office. The patient did not seek medical attention. No laboratory diagnostic studies were performed and no treatment was given for the event. The outcome of a 1 inch red "hive-like" bump near the injection site was reported as recovering at the time of the report. The relatedness between the event and MMR II was not reported. Additional information has been requested.
Syncopal episode lasting 10 seconds. Patient reported not eating or drinking before. Blood pressure 78/54, O2 saturation 100%.  Patient drank water and apple juice. Blood pressure 117/70. Blood sugar 142. Patient evaluated by MD. Repeat blood pressure 116/66. Patient released home with mother.
At about 9:30 pm10/11/22, I began experiencing extreme aches throughout my entire body. I became very cold and was unable to breathe through my nose. I was unable to sleep comfortably and woke up with continuous, persistent coughing, a fever and significant amount of phlegm that oven been trying to expel as often as possible but can?t seem  keep up.  In addition, I cannot smell and can only taste only strong  flavors. That next day, I felt like I had the COVID virus ( I had a mildly severe  case of the second variant in Mar 2021) or the worst flu I?ve had in years.      This feels very similar to having the virus despite being  fully vaccinated and boosted. Other vaccines/booster shots only affected my sleep and  fatigue. I didn?t have such a significant flu-like, COVID-like  after the  three other shots (all Pfizer vaccines and first booster)  In addition, the knee that I had surgery on five months ago has swollen up and I?m  in excruciating pain despite being bed ridden for three 1/2 days.
No adverse event; we gave him a dose of Moderna bivalent (pink cap) yesterday, he should have received a Moderna bivalent blue cap 0.25 ml dose; This spontaneous case was reported by a non-health professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (we gave him a dose of Moderna bivalent (pink cap) yesterday, he should have received a Moderna bivalent blue cap 0.25 ml dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (we gave him a dose of Moderna bivalent (pink cap) yesterday, he should have received a Moderna bivalent blue cap 0.25 ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (we gave him a dose of Moderna bivalent (pink cap) yesterday, he should have received a Moderna bivalent blue cap 0.25 ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  The patient received a monovalent dose of Moderna vaccine on 27-Sep-2022 with lot number AR9237B.  The patient should have received a Moderna bivalent vaccine with blue cap of 0.25 ml dose instead of receiving the Moderna bivalent vaccine with pink cap.  Treatment information was not reported.
Sore arm, fever, myalgias, worsening of urticaria. 1 day of symptoms.
The pt experienced pain and swelling to about 5 cm. Lasted 5 1/2 days. Appeared to be "arthus" reaction. The pt had a fever.
pt recv vax 6JUL98 in evening arm was sore;pt arm had sl yellow discharge;pt declined a bandaid p/inj;7JUL98 evening arm was more edematous & painful;dx cellulitis;10JUL98 lt arm red, swollen, low fever;
p/vax pt exp chickenpox;pt devel less chickenpox than other two siblings;reporter felt adverse exp was r/t vax;
States 10/2/12 about 500pm not feeling well, began to run low grade fever (99.7-99.8) had chills, weak, no appetite, could not eat, diarrhea. Went to doctor 10/3/12 diagnosed with colitis. Says 7 days in bed able to return to full duty 10/16/12.
Diagnosis of ITP (immune thrombocytopenic purpura); Spontaneous rectal bleeding; Little bit of soreness; A spontaneous report was received from a consumer concerning reporter's mother a 90-year-old, female patient, who was diagnosed ITP (immune thrombocytopenic purpura)/immune thrombocytopenia, body's immune system attacking its own immune system/autoimmune disorder, spontaneous rectal bleeding/rectal haemorrhage, platelets abnormal/platelet disorder and little bit of soreness/pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, patient's blood platelets were zero which was considered as life threatening event. On 13 Feb 2021 Saturday, patient had spontaneous rectal bleeding for which patient was taken to emergency room and admitted to ICU. Then patient was transferred to another hospital where patient was diagnosis of ITP (immune thrombocytopenic purpura) where body's immune system attacking its own immune system. The patient was seen by hematologist for 8 days. After vaccination the patient felt little bit of soreness, but patient was completely fine.   The patient had three platelet counts one on 13 Feb 2021, in which showed a result of zero platelet, on 22FEB2021 platelet count increased to 57 and unknown date patient platelet count was 357. The patient also had tested for leukemia, blood cancers, and other blood work came normal.  Treatment for the event included two Blood transfusions, IV steroids, Oral steroids maximum dose, Rituxan, N-platelet injections nonspecific.  Action taken with mRNA-1273 in response to the events was not provided.  The events, ITP (immune thrombocytopenic purpura), body's immune system attacking its own immune system, spontaneous rectal bleeding, platelets abnormal and little bit of soreness, were considered recovering on the time of reporting.; 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.; Sender's Comments:  MOD-2021-047223:Crosslinked case
severe sore throat; very painful to swallow; flaming red posterior pharynx; flaming red posterior pharynx; This is a spontaneous report from a contactable physician (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 14Jan2021 at 14:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included hypertension, breast cancer, seasonal allergies, and depression. Concomitant medications included unspecified medicines. The patient previously took doxycycline and had allergies; and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283) on 24Dec2020 at 07:30 am in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 17Jan2021 at 06:00, the patient started getting a severe sore throat, very painful to swallow. The patient had no fever, no lymphadenopathy, no tonsillar excavate, just flaming red posterior pharynx on 17Jan2021 at 06:00. The reported events led to doctor office/clinic visit and emergency room visit. The doctor thinks these may be a reaction to the vaccine, however, the patient did not receive any treatment for the reported events. On 18Jan2021, the patient underwent throat swab and nasal swab tests and both were negative. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
12 hr post - chills and fatigue, 24 hrs  - fatigue, generalized aches preceded syncopal event while seated with sweating , blurred vision then loss on consciousness  for 15 seconds. Revived on floor with tachycardia, sweating  then nausea and vomiting x 1.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no pertinent medical history or drug reactions/allergies. On 26-JAN-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX vial (lot # K012924, expiration date reported as 29-NOV-2015), once, subcutaneously. No co-suspect therapies were reported. There were no concomitant medications. The pharmacist reproted that on 28-JAN-2015, the patient called in to the pharmacy stating that she developed a "red, itchy rash or patch" at the injection site that was "red and warm to the touch" (approximately in January 2015). No treatment was given for the adverse events and no lab diagnostics studies were performed. At the time of the report, the patient had not recovered from the events injection site rash, injection site pruritis, injection site erythema and injection site warmth. Additional information has been requested.
Injection site reactions---Within 30 minutes itching all around injection.  Within 2 hours red area.  Within 5-6 hours, very itchy, very red, very swollen, hardened area; arm painful; affected area is 5" x 3 1/2".  On 4/8/16 symptoms still there but less intense; affected area enlarged to 5" x 4 1/2".  On 4/9/16 still swollen and red and painful; affected area now all the way down to my elbow; upper area discolored like a bruise.  On 4/10/16 symptoms lessened greatly.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-AUG-2017 the patient was vaccinated with an expired dose of GARDASIL 9 (lot # L044475, expiration date 17-MAY-2017, dose and route unknown) for prophylaxis (experienced expired product administered). GARDASIL 9 did not have any previous temperature excursions. No adverse symptoms were reported.
6APR92 pt recvd MMR vax on 8APR92 pt c/o joint pain (severe) below neck, shoulder, arms & back; arms & hands tingling-hands dangling to sides; rash on face & has hot fever; pt saw MD today; given med; pt weak, back & shoulder pain; no appet
Feel little stinks; Headache; Feel like tired; Chilling; Muscles pain; Cold; This is a spontaneous report from a contactable consumer or other non hcp. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Feb2021 (at the age of 35 years old), 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the shots of COVID-19, yesterday (03Feb2021) was her second shot and feels little stinks, she has headache, feel like tired, chilling, muscles pain and cold. And she wants to know if it is, on it paper it is normal but for her but like for like her family. The number 82, so the name of the shot they told her, she has a number, and it is 82, she don't know if it is that one. Therapeutic measures were taken as a result of muscles pain. The outcome of the events was unknown.  Follow-up (16Apr2021): 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 have been completed and no further information is expected.
Chills and elevated temp 12 hours after injection.  Symptoms were over by 7am following morning except for residual tiredness.
fever, chills, body aches, diarrhea, nausea x 4 days and still ongoing.  temp 101-102 F Side effects worse that after dose 1 and longer lasting. palpitations/tachycardia
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. For tolerability after receiving SHINGRIX, refer case US2018104483.