chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extremely fatigued; legs are very weak hard to stand sometime; legs are very weak hard to stand sometime; very thirsty; This is a spontaneous report from a contactable consumer reporting for himself. A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9263), via an unspecified route of administration in the right arm on 26Feb2021 09:30 AM (at the age of 72-years-old) as single dose for COVID-19 immunisation in the public health department.  Medical history included allergy with shellfish. The patient has no other medical history. The patient had no concomitant medications. The patient did not receive any other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3248) in the right arm on 05Feb2021 at 09:30 AM (at the age of 72-years-old) for COVID-19 immunization. The patient reported that there was no fever, no pain. Just extremely fatigued, legs were very weak, hard to stand sometime and very thirsty on 05Mar2021. The events resulted in emergency room/department or urgent care. The patient received four bags of fluids as treatment for the events. The patient was not diagnosed with COVID prior to vaccination. The patient tested negative in a COVID-19 test via nasal swab on 15Mar2021. The outcome of the events was not recovered.
Sluggish starting morning after immunization. Motor still regression. Follow-up info received states immediately after vaccination child became "paralyzed and weak". Mom took child to see MD on 1/22/02 and was given a referral to neurology. The appt was not for nearly a month and on 1/24/02 child was "suddenly better" and able to walk better.
No atypical sx reported. Muscle/injection site soreness. Injected subcutaneous vs intramuscular 1st dose.
Crying for 8hrs, sometimes high pitched; Fever 102.2, unconsolable; Resolved @ 24hrs p/shot; 2 sibling also had rxn w/previous inject;
Soar arm at the injection site on 3-20-2021 and dry cough starting on 3-21-2021
After administration, patient stood up, and started walking away. Got 3 steps away, told mom that he couldn't see.  Pharmacist immediately helped mom get patient over to bench.  Quickly patient's coloring turned pallor, breathing abruptly slowed.  Very shallow and difficulty breathing.  Eyes rolled back in head. Sweat through entire shirt. Pharmacist used EpiPen JR to right thigh (Lot number4GN349, Exp 12/15). Called 911. Over the next 10 min, breathing returned, vision returned, ability to talk returned. Paramedics came and walked next to patient and mom.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MUCINEX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with Paxlovid from 06Jul2022 to 10Jul2022. Other medication in 2 weeks: Yes. Other medication in 2weeks include Mucinex.   No follow-up attempts are possible. No further information is expected.
BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body ache and headache was not reported. This report was non-serious.
Backache (moderate), stiffness in legs (moderate), cold chills with shaking (moderate), Headache (mild) Side effects gone by morning of 4/2/21.  Note: legs are most affected by MS, though mild.  Still ambulatory. Thinking legs were affected due to existing weakness from MS.
This spontaneous report concerning a 4 months old patient was received from a registered nurse. The patient's concurrent conditions and medical history were not provided. On 13-JUL-2016, the patient was inadvertently vaccinated with VAQTA (inappropriate schedule of drug administration)(lot # M022531, expiration date 23-FEB-2018, strength, dose and frequency were not provided) by intramuscular route. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. Additional information has been requested.
PATIENT PRESENTED TO MY PHARMACY ON 11/12/19 WITH HER LEFT ARM SLIGHTLY INFLAMED AND RED. SHE REPORTED IT STARTED THE NEXT DAY, SHE APPLIED ICE  THROUGH THE WEEKEND AND IT WAS GETTING MUCH BETTER THAN IT WAS PREVIOUSLY. I ADVISED HER TO CONTINUE WITH THE ICE AND CALL HER REGULAR MD IN THE MORNING IF NO IMPROVEMENT
High fever started 6 hours after injection along with shaking/chills. Intense headache as well.  1,000mg Tylenol brought fever down to about 103.6. After talking with doctor, placed in cold shower and also gave 400mg advil.  He calmed down and fell asleep for 7 hours. Woke and no fever but achy and tired for remainder of the day. Woke up the following day (so about 36 hours later) and felt much better.  All is fine now.
I had Covid-19 twice on Dec 19 and Jan 10th. I had ear pressure. I then had cold like symptoms. I had fatigue. Then, my second Covid-19, I had a sore throat, severe fatigue, SOB, ear pressure, and headache. I also had chest pain. I went to my doctor about it. They did a chest x-ray and put on an inhaler.
That night, began with tics (no prior history of tics) which were increasing in frequency over the next 24 hrs and then started to space out and resolved about 72 hrs after onset
This solicited report was received from a non-healthcare professional (unspecified role) and refers to unspecified number of patients of unknown demographics, enrolled in a Market Research Project. The patients' medical history, concurrent conditions and concomitant medications were not reported. In reply to the question "For what reason(s) were you not open to consider vaccinating your children against HPV in the future", the reporter stated that knew people, who on an unknown dates were vaccinated with doses of GARDASIL injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Then, on an unknown dates, they experienced unspecified severe reactions. The outcomes of severe reactions were not reported. The causality assessment was not provided. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 13-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Fever (100.5) Chills Headache Loss of Appetite Fatigue Muscle aches
Case number PHEH2014US003807 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 14 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 006031A and expiry date: JUN 2014), at a dose of 0.5 ml intramuscularly on 16 JAN 2014 in the flu clinic. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indications as "drug used in unapproved population".
Pt reports of syncope (fainting) twice immediately after receiving the vaccine. First one occurred within a minute of receiving and second one occurred five minutes later according to patient and mother of patient who accompanied the patient. Patient reports that the facility called for paramedics whom found the patient to be in stable condition. Patient reports that paramedics informed that her BP and blood glucose levels were in normal range. Patient expressed of having anxiety about the vaccination and having nauseous feeling just before administration and "imagining the needing going into the muscle" as she was receiving the vaccine. Patient was assessed in the office roughly 2 hours post vaccine. Patient's history is clear of any diagnosis and patient was not on any medication. Patient stated that she feel well. Pt. is diagnosed of having vasovagal syncope and was educated to monitor and report any other symptoms. Need for blood work or lab assessment was discussed.
Sensation of throat tightening a few minutes after administration.  Could still breathe and Went away after about 20 minutes. Swelling and redness and pain at injection site for 3 days. No medications were given for reactions.
Myalgias, fever, headache occuring 24 hours later with slow improvement, severe enough to require time off from work
Pt rec'd Pfizer 3/4/21 and 3/25/21 both from facility, then Moderna booster 11/16/21. Pt to ED 1/31/22 c/o SOB. Dx acute hypoxic resp failure. CXR and CT show large mass encroaching on R mainstem bronchus. Admitted to ICU and placed on vent. Pos COVID Pcr in ED. Hypotensive with pressors. After continued deterioration changed to DNR/DNI. Discharge dx: septic shock, acute hypoxic and hypercapnic resp failure, poorly differentiated adenocarcinoma of lungs with distal metastasis, pleural effusion, COPD exacerbation, COVID-19 pneumonia, lactic acidosis, tobacco use disorder, moderate hypercalcemia, D dimer elevated, abnormal head CT (mets), pericardial efusion w/o tamponade, acute renal failure/anuric, metabolic acidosis, respiratory acidosis, constipation, shock liver
SNEEZING; Chest tightness; COUGH; RUNNY NOSE; PAIN IN THE ARM; COPD; Asthma; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), COUGH (COUGH), RHINORRHOEA (RUNNY NOSE) and PAIN IN EXTREMITY (PAIN IN THE ARM) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic pain and Non-smoker.    On 27-Jan-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 29-Jul-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ASTHMA (Asthma). On an unknown date, the patient experienced COUGH (COUGH), RHINORRHOEA (RUNNY NOSE) and PAIN IN EXTREMITY (PAIN IN THE ARM). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), COUGH (COUGH) and PAIN IN EXTREMITY (PAIN IN THE ARM) outcome was unknown and RHINORRHOEA (RUNNY NOSE) and HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Chest X-ray: asthma and copd (abnormal) she had Asthma and COPD.         Relevant concomitant medications were not reported.   This case was linked to MOD-2021-278377 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received include ethnicity, medical history, treatment medication and newevents added.
Redness and swelling at the site of injection on left arm where she had her flu and Tdap. It has now spread to a bigger area as of 10/03/16. No itching but has slight pain, redness, and feeling of heat. Pt was told to put Ice, Ibuprofen, and BENADRYL on 10/3/16.
Numbness, tingling, pain. Dx: brachial plexus neuritis.
I had  dizziness, headache, chills, fever of 100.7 .
Shingles; inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 48-year-old female patient who received Herpes zoster (Shingrix) (batch number 497D9, expiry date 11th September 2021) for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th June 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 7th July 2019, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Pharmacy Intern on the line. 33 days after receiving Shingrix in the left arm, the patient experienced a shingles outbreak and started acyclovir with an unknown dose on an unknown date. The reporter consented to follow up. The outcome reported for the event in the structured field is "resolved with sequelae" instead of "recovered/ resolved" (outcome uploaded).
She received her second dose of SHINGRIX, approximately 80 days after her first dose. She reported excessive night sweating for the first 2 nights after receiving the second dose of SHINGRIX. She stated this side effect did not happen after her first dose.
nonproductive cough, body aches, chest pain, sneezing. starting 11/16/21
Erythema 12x13cm at injection site 4 day s/p injection.
Around 4 AM on the day after receiving my vaccine, I experienced a fever and generalized seizure with a loss of consciousness
received both the Moderna and Pfizer vaccine 18 days apart; received both the Moderna and Pfizer vaccine 18 days apart; more pronounced swelling in legs; weakness in her lower extremities; very weak; very difficult for her to walk; legs are really sore; really painful and tender in certain areas when touched; really painful and tender in certain areas when touched; more of the confusion; This is a spontaneous report from a non-contactable consumer reported for a female patient (reporter's mother). A 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 28Jun2021 (age at vaccination was unknown) as dose 2 (initial Pfizer dose), single for COVID-19 immunization. The patient received COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Jun2021 (age at vaccination was unknown) dose 1, single for COVID-19 immunization. Prior to vaccination, the patient had pneumonia and shortness of breath. She went into the hospital on 03Jun2021, was admitted on 04Jun2021, and discharged on 17Jun2021. She was given antibiotics during this time. Prior medical history included high blood pressure, asthma, heart problems, dementia, and swelling in legs. Concomitant medication included carvedilol, chlorothiazide, tiotropium bromide monohydrate (SPIRIVA), albuterol sulfate, pantoprazole, allopurinol, losartan and memantine HCL all taken for an unspecified indication. The caller stated there were other medications, but she did not have it. The caller reported an adverse event her mother experienced. She was notified on Friday that her mother received both the Moderna and Pfizer vaccine 18 days apart. The patient received the Moderna vaccine as a first dose on 10Jun2021 at the rehabilitation facility and the Pfizer vaccine on 28Jun2021. Since vaccination, patient had the following symptoms: more pronounced swelling in legs, weakness in her lower extremities, very weak, very difficult for her to walk, legs are really sore, really painful and tender in certain areas when touched, and more of the confusion. The patient did not receive any medications for these side effects. The caller asked if her mother's side effects were common. The caller asked if her mother was fully vaccinated as she received two different brands 18 days apart. She asked if it was commonly reported for patients to receive two different brands. The patient was not hospitalized for the reported events since the vaccination. No treatment was received for the adverse events. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Tinnitus, some "whooshing sounds" about a week later, then on 6/23/2021 - ringing in both ears, loud, seems to get worse every morning, a little better through out day.
Rash, itching, hives - started 10-26-13 "Flu-like symptoms" started 10-27-13 and hospitalized 10-28-13-BP -> 160/120 HR-> 132 fever -> 101 chest xray showed fluid on lungs.
Varicella vax, #1 Routine no known exposure on approximately 8/22/00. 8/30/00 noted few spots on trunk on 8/31/00 typical, numerous, uncountable number varicella lesions. T 100.1 otherwise well on 9/6 only crusting lesions.
12/9-Received call states 24 hours post vaccine she developed hives to upper body, denied DIB. Took BENADRYL and applied hydrocortisone to areas. Has improved.
She developed a fever and was screaming, without being able to quiet her. Her legs, arms and head swelled up. Swollen all over. Mother took baby to Emergency room and was given Benadryl. Private Doctor told Mother is was the pertussis that caused the reaction.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender.  The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX (dose and route unknown, lot # L017145, expiration date: 13-MAY-2017) for prophylaxis. The vaccines were stored in -11.2 degrees Celsius for 15 hours 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1702USA011265:
Severe head and body aches, chills, a little nausea and just felt sick all over but only lasted  about 12 hours and then I felt fine.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Feeling hot, Sneezing, runny nose- 11/2, followed by fever and nausea in the evening of 11/2 and  on going to 11/3. Pain left arm sore, and fatigue/tiredness. Over all not feeling well.
7 Days after MMR and Hep A were given in left upper thigh, child developed swelling & redness. No fever. No limited motion. She did not cry when topical medication applied. Taken to acute care-walk in center 1-14-12 and given SEPTRA. Parent informed at that visit to go to PCP for "form to be completed".
Pain in left arm (where injection) became painful (throbbing also) immediately (within 24 hours); Since then pain has been severe with throbbing, (intermittently) and loss some range of motion! By 2-19-08 pain has worsened, not lessened. Severe pain left arm only!
Exactly one week post vaccine, I developed red bumps on my left upper arm directly underneath my vaccination shot. The red bumps were only itchy to a touch. The next day, the red bumps expanded into each other and formed one large irritation area (about 4 inches by 5in) and sore to touch. Tactile temp of 99.1. On the third day, the formation is still present. The redness is uneven and looks a bit larger than before. Slight weakness in my left arm. No other symptoms.
fluid in lungs; swelling in ankles; shortness of breath; slurring of words; my balance is off; This is a spontaneous report from a contactable consumer (patient).  This 78-year-old female patient received  the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 18Mar2021 08:45 as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Medical history included allergies: Some high blood pressure medications. Concomitant medications included "Hyperion meds". The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9269), via an unspecified route of administration in the left arm on 25Feb2021 08:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported, "I had fluid in lungs and swelling in ankles. I now have slurring of words to the point I am unable to pronounce it, walk with a cane because my balance is off. I am walking very slow. I don't feel safe to drive and have canceled doctor's appointments. I also had shortness of breath." These adverse events were reported started on 25Mar2021 18:00 and resulted in emergency room/department or urgent care. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, fluid in lungs and swelling in ankles, slurring of words and my balance is off, was not resolved as of 20Apr2021.
ON 1/19/21 DEVELOPED NAUSEA. FOLLOWED UP WITH PCP.
2PM recd TD vax; 8PM c/o feel bad, h/a, no meds taken; 9PM to bed; 23AUG91 5AM hot, nausea, as if neck swollen; 7AM took ASA & slept; 1PM "felt worse", fever, chills, h/a; 235PM T101, ears & throat red; dx ear infect aggr by TD vax; rx;