chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 29-JUN-2017 from a nurse regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of VAQTA (lot number M039055, expiration date 22-JUL-2018) (dose, route, site of administration not reported). The nurse reported the medication was improperly stored. Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit, Time frame: 10 minutes, Previous excursions: no, Was call due to data logger: yes. No adverse effects were reported. The outcome of the event was unknown. No additional information was provided. Additional information has been requested.
Information has been received from a physician concerning a 16 year old Hispanic female who on 24-MAY-2007 was vaccinated with her first dose of Gardasil. There was no concomitant medication. On 25-MAY-2007 the patient developed nausea, dizziness, weakness and was tired.
Wife develop symptoms of COVID after fully vaccinated; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED COVID-19 (Wife develop symptoms of COVID after fully vaccinated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced SUSPECTED COVID-19 (Wife develop symptoms of COVID after fully vaccinated). At the time of the report, SUSPECTED COVID-19 (Wife develop symptoms of COVID after fully vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. Case is linked with MOD21-159174  This case concerns a female patient with unknown age, no relevant medical history, who experienced the non-serious unexpected event of Suspected COVID-19. The event occurred on an unknown day after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AE occurred after the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding vaccination dates is incomplete, so lack of efficacy situation cannot be properly assessed.; Sender's Comments: This case concerns a female patient with unknown age, no relevant medical history, who experienced the non-serious unexpected event of Suspected COVID-19. The event occurred on an unknown day after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AE occurred after the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding vaccination dates is incomplete, so lack of efficacy situation cannot be properly assessed.
Body aches, fever of 99.6, chills, fatigue one day after second shot.  First shot on 3/10/2021 resulted in joint and muscle pain in hips, knees, hands several hours later and lasting for approximately 5 days.  That was lot EM9810.
fair amount of bleeding after the needle was removed; good size bruise; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Other products, patient history and investigation assessment was No. There were no concomitant medications.She provided her weight as 140, 142, or 143 lbs. After administration of the COVID 19 vaccine there was a fair amount of bleeding after the needle was removed. It could have been the administration process. Another resident here had the same experience, but she was unsure if the resident received the Pfizer of Moderna vaccine. This was day 5 and the caller still had a bruise. The current caller said she developed a good size bruise, and she didn't bruise easily. She didn't have a prescribing doctor. She got it at the city hospital, where she worked. She was not on anticoagulants. She had not taken aspirin or Motrin. The outcome of the event bruise was not recovered, of other event was unknown.
Pt recv vax on unknown day; post vax pt exp chills, fever, up all night, sluggish
Later in the same day as the injection I noticed the normal soreness/tenderness in my injection arm which lasted about 3 days. The 4th day after my injection I noticed a large lump and redness at the injection sight. 7 days after my injection I noticed the lump had gone away but I now had a large red blotchy ring at the injection sight. I still have this blotchy red ring on my arm 10 days after my first injection.
mom noted temp of 101 (ax) about 1 1/2-2hrs p/vax;temp down to 99.8 ax @ 4:30-more APAP given;mom noted rash on chest;24APR95 rash is fine, raised & pink on face; 23APR95 sleepy all day; 24APR95 not eating well;mom called PMD on 24APR95
He?s complaining of pain all over hot and a terrible headache . He was crying when he called .  He said that he was confused when he woke up and didn?t k ow where he was . He went to get his socks amd went to the refrigerator to look for them . He said he?s never felt this bad his entire life not even when he had his 8 mm disc bulge 10 years ago . Pain in every joint . Unknown temperature  . Urinating a lot .  A do I already pain unbelievable pressure in his head  ears sinus and back of neck giving him a zing and zap sensation . The water in the shower felt like thousands of needles . I?ve never seen him like this .
mom noticed pt having involuntar face, grimaces involving tongue, mouth, twitching & blinking eyes, constantly twitching of head & neck also;presently not improving
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Side effects after the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Muscle locking in the left calf. Intense muscle cramping and intense burning pain in the left back quadrant.
After 5 minutes of vaccination she started to have shortness of breath, and ambulance was called out of caution
No additional AEs or PQC reported; Caller reported VARIVAX was administered subcutaneously in the abdomen to a 40 year old patient. No other information provided.  No additional AEs or PQC reported.; dose: 1 ml; This spontaneous report was received from a pharmacist referring to a 40 years old male patient. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 30-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength was not reported;  lot# U016864, which was not valid, expiration date: 20-MAY-2023) 1 ml, subcutaneously (sq) for prophylaxis in the abdomen (product administered at inappropriate site and incorrect dose administered).       No additional adverse events were reported.
Pt developed scattered urticaria and itching. No oral involvement or respiratory difficulty. Resolved within 24 hrs with 2 doses of BENADRYL.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 01/29/21, 3/6/2021 and 9/23/2021. COVID + on 1/11/22. Presented to ED on 1/16/2022, intubated and sedated after being found unresponsive at home with O2 in 50s. Recently discharged on 2.5L NC from outside facility for COVID PNA (1/11 - 1/15).  Treated with solumedrol, rocephin, and remdesivir at outside facility. Once admitted, found to have complicated UTI with stenotrophomonas maltophilia and Serratia rubidaea. treated with cefepime then ceftriaxone. Renal function continued to worsen despite treatments and supportive measures. DNAR. Expired 1/27/22.
Pt presented to Covid Vaccine Clinic asking for first dose of Covid vaccine and was given the Pfizer shot. Upon entering his dose into the vaccine tracking system did we discover he had already received two prior doses of Pfizer on 12-17-20 and 1-7-21.   No known adverse medical issues have been reported by this patient.
4/2/2023 I had pain in the left ear that progressively got more painful. Then Bells Palsy kicked in. The left side of my face was not moving. It got worse the next day. I went to the doctor, and he thought I had an infection and was prescribed Gabapentin. I got worse for a couple of days, then I have slowly been getting better day by day, but I still have issues.
Per my corporate policy, we need to report that the patient got a Johnson and Johnson shot on 3/13/21 at another site. This was not caught on the review on 6/29/21 when the pt came to get a Pfizer vaccine to cover against the Delta Variant.  The situation was noticed when the pt came to receive her second Pfizer shot at the end of July (7/22/21).  The patient was informed that pharmacists at this time cannot administer a Pfizer vaccine to recipients of other Covid Vaccines, including Johnson and Johnson.  Pt reported she had no side effect after receiving the Pfizer shot-
Her hair fell out as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200531842 (Pfizer Inc).  A female patient in her 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Her hair fell out as well".  Additional information: The reporter nephew married a girl who was in her 30's. Her hair fell out as well. So, it was something with the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upper right arm/shoulder pain. Difficult to pull up arm. Comes and goes in intensity of pain.
This spontaneous report was received from a 63 year old female patient and refers to herself. The patient's medical history included cervical cancer (recovered). The patient's concurrent conditions included codeine drug reaction/allergy. On 08-JUL-2016 (reported as 10 days ago), the patient was vaccinated with ZOSTAVAX (1 time injection, route of administration was reported as injection, dose, lot# and expiration date were not provided) as shingles prevention. Concomitant therapies included lisinopril (manufacturer unknown) and EFFEXOR. On 15-JUL-2016, the patient began to have liquid filled pustules around the injection site on her arm. The patient sought medical attention. There were no lab diagnostics studies performed. An unspecified treatment was given for the adverse event. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.
she got her second dose, and the lymph nodes under her left arm got bigger, and the lymph nodes under her right arm also grew; she got her second dose, and the lymph nodes under her left arm got bigger, and the lymph nodes under her right arm also grew; She stated this was not comfortable; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not provided) via an unspecified route, administered in arm on an unspecified date as dose 2, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on 16Feb2021 and noticed swelling in her lymph nodes after the first dose but got the second dose 3 weeks later and was still having this swelling. She stated she talked to the doctor when it didn't go away for a month and he said give it a week or two. After that he said to send pictures and said give it another month but now it has been 3 months. She stated that everyone else to whom she spoked to that experienced told that it would be resolved in a couple of weeks. She stated this was not comfortable. She asked how long swollen lymph nodes was supposed to lasted. She stated she put in a message to her doctor again today. No investigation assessment was reported. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
This spontaneous report was received from a nurse regarding a female patient of unknown age. The patient's pertinent medical history and drug allergies were unknown. On an unknown date, on 2011 the patient was vaccinated with her first dose of GARDASIL, route not reported. There was no information of concomitant medications. The nurse stated that the patient received her first dose of GARDASIL on an unknown date in 2011, and on 26-JUN-2014, patient came into the office to receive her second dose of GARDASIL. No adverse effects was reported. There was no product quality complaint involved. Additional information has been requested.
Parent said after last imms; patient c/o arm itching and he had little bumps at site on left arm. This was noticed 2-3 days after imms. Father said no other complaints or signs or symptoms. Father said he thought this was just the normal itching that patient has sometimes. Father said he didn't treat or seek medical help area.
Developed hive-like rash on R hand and forearm two days after Td vaccine administered to R deltoid.  Patient also received PPD on L forearm on day of vaccination.  Hx atopic rxns.
Achy; Headachy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and HEADACHE (Headachy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced PAIN (Achy) and HEADACHE (Headachy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achy) and HEADACHE (Headachy) outcome was unknown.            Patient also reports being on 2 or 3 daily regular medications before the vaccine. Patient reports similar late onset reactions from the second dose.   This case was linked to MOD-2021-046491 (Patient Link).
Pt has had worsening dyspnea and cough since 2/11/2022.  Pt admitted for acute hypoxic respiratory failure and COVID-19 viral pneumonia.
Per Son of patient - he mentioned that many hours after patient received vaccine that he called and reported shaking uncontrollably. The patient was taken to the hospital by the son and it was reported that a cardiac enzyme was elevated and patient was treated in ER for 6 hours. Son states that MD was not sure if it was a reaction to the vaccine but stated it was possible. Patient had no prior history of allergy to flu vaccine or components. Patient had a regularly scheduled appt with primary care MD on the following week and it was recommended to also let MD know to put note in chart. Per the son, not further issues or adverse reacts have come about since patient got home from hospital
At 3:30 am woke up needing to throw up. Had some diarrhea. Went back to bed. 5am full body ache, severe headache, severe fatigue. Took a tylenol and shower. Napped from 9am to 10:45. Woke up freezing. Temperature taken 100.5 degrees with upset stomach. No desire to eat. Crackers make stomach upset.
Pt woke up the morning after receiving flu vaccine with red raised rash to legs, arms and torso, being treated with oral and topical BENADRYL.
Product storage error; no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-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 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error ) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Product storage error ).    This case contains information for the 10 out of 15 patients as described by the reporter.  No concomitant medication information was provided.  It was reported that that they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date. Lot number AS7168B, beyond use date 08Jan2023. Administration dates were as follows: 09-Jan-2023 (2 patients) 10-Jan-2023 (2 patients) 11-Jan-2023 (4 patients) 12-Jan-2023 (4 patients) 13-Jan-2023 (3 patients). All of the patients were 12years and above but HCP did not have the information if some of them were below 17 years old.  No treatment medications were provided.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566:MASTER  CASE
woke up w/pain on rt side trunk under rt arm, rt bad tenderness, rt groin pain, lumbar pain;2 ASA in PM helped;rt sided pain less severe today;
COVID Breakthrough. Patient presented to the Emergency Department on 12/1/21 for back pain, fever, and cough going on for 3 days. She tested positive for COVID in the emergency department.
diarrhea; queasiness; headache; fever; soreness; chattering teeth; chills; exhausted; A spontaneous report was received from a 51 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and experienced fever, exhaustion, chills, soreness, chattering teeth, diarrhea, headache and queasiness.   The patient's medical history was not provided. Concomitant medications reported included famotidine, atenolol and oxymetazoline hydrochloride.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J2/2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 1 Jan 2020, patient reported fever, exhaustion, chills, soreness and chattering teeth. On 7 Jan 2020, patient started to feel bad again with fever, chills, exhaustion, diarrhea, headache and queasiness.   Treatment for the event included ibuprofen and then paracetamol.   Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events, fever, exhaustion, chills, soreness, chattering teeth, diarrhea, headache and queasiness were considered unknown.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache, fever , nausea and chills are consistent with the known safety profile of the vaccine.
Fever (99.5-102.5) x 30 hours post vaccination, drowsiness, lack of appetite, irritability, resltess sleep, and peri-oral urticaria.  Symptoms began within 1 hr. of vaccination and still present at hour 30 in PCP office.
Patient developed an itchy throat with a "lump." We administered 25mg of benadryl and monitored for 30 minutes.
High fever, arm swelling, flu-like symptoms x 2 days. Treated with Benadryl. Symptoms lasted 2-3 days. Did not see doctor or report symptoms at time of adverse event.
Have had tinnitus for a number of years, but the volume has always been at a reasonable level such that it was never disabling.  I was awakened on the morning of March 24th by considerably louder tinnitus ringing in both ears and was unable to sleep thereafter.  This condition persisted throughout the day, causing significant stress and anxiety and making normal function extremely difficult.  That night, I was unable to sleep at all.  Though the volume has diminished somewhat, it is still close to being at a debilitating level, making normal function exceedingly difficult.  Receiving the vaccine was the only change in my normal routine, so I am attributing this condition to that.At this point, I have determined not to get the second dose of the vaccine.