chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms; felt as if she was "hit by a train"; pain in her arm; difficulty getting out of bed; first dose of Shingrix about a year ago / never received her second dose; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, pain in arm, mobility decreased and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, general body pain, pain in arm, mobility decreased and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received 1st dose of Shingrix about a year ago from the date of reporting, The patient felt as if she was hit by a train, also experienced pain in her arm, difficulty getting out of bed and she felt flu-like symptoms.  The patient did not remember the arm she received it on since it was almost a year ago.  The patient never received her 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to following up with her physician.  The reporter did not consent to follow up.
-Sore arm:  started about 2 hours after injection.  By 18 hours after, it felt like I had a really bad bruise there.  It was throbbing always, more painful to stretch the deltoid where the shot was given, and sharply painful if I used that muscle to lift my arm.  This continued until about 30 hours when it started to reduce in intensity until being gone about 60 hours (2.5 days) after the shot. -General lethargy:  started about 6-7 hours after shot.   Peaked about 24 hours.  Still able to get up and move around but very tired.  Gone at about 43 hour mark. -Body aches:  timeframes the same as lethargy.  Felt at worst like a bad flu. - Headache and lightheadedness:  Started about  2 hours after injection.  Never got really bad, but was fairly consistently there until about 36 hour mark. - Burning eyes: started about 7 hours after shot, was annoying and lasted until about 33 hour mark. - Coughing:  mild but distinct dry cough started about 18 hours after shot and lasted to about 30 hour mark.
Chills; Fever; Body aches; Headache; weird shallowness when breathing; Elevated heart rate; Restless; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Apr2021 (at the age of 39-years) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) on 24Mar2021 for covid-19 immunisation. She had no side effects after the first vaccine. Caller had the second dose of the Pfizer covid19 vaccine on 17Apr2021 around 11:15 AM. A few hours after the vaccine she had chills, fever, body aches and a headache. That has subsided. Currently she has shortness of breath and an elevated heart rate. She felt uncomfortable when having a lengthy conversation or going up and down the stairs. She felt restless, and has weird shallowness when breathing. Caller stated she doesn't know if it is blood clot related or something else. Caller stated she already contacted her health care provider and was going to wait for them to call her back. She refused to complete the safety report. She was under the impression that she would get advice on what to do next. Clarified that we do not give advice, but she may contact MI for product side effects or ingredients. Advised her to contact her doctor for any medical advice. The outcome of the event restless was unknown; events elevated heart rate and short of breath were not recovered and recovering for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Breakthrough case admission after 3 vaccines pfizer 2/26/21 Lot# En6202; Pfizer 3/19/21 Lot# En6206;  Pfizer 10/2/21 Lot# FF2589
The next morning, every joint ached and could hardly move. Shot was received on 11/1/13, patient symptoms developed the morning of 11/2/13.
DEATH!  About 24 hours after getting his 2nd Moderna Covid-19 shot, patient got deathly ill with explosive vomiting and diarrhea. Not long later he was passing out.  Paramedics were called, and he was taken to the hospital where he passed away from a massive heart attack. The doctors gave him clot-busting drugs in an attempt to save him.  He has never had problems with blood clots in his life.  He was the healthiest one of us all,  and was almost never sick. The doctor said that it was probably no coincidence that he died so soon after receiving his Covid shot. I am convinced that they are connected.  A healthy man suddenly gets blood clots in his heart 24 hours after getting his shot?  Not a coincidence!!!!!!!!!!!!!!1
Developed fever within 12 hours. Severe head ache and muscle aches within a couple hours. Mild cough in 10 hours.
Client given Td booster on 8/27/02 and returned to clinic on 8/29/02. Complained of left deltoid large amount of redness, skin tight, warm to touch and painful at injection site. Redness measures 80mm length and 55mm width. Client denies nausea and afebrile.
Also received: on 9/4/2019 SHIGRIX Lot#4RR52 Exp 12/7/20121 left arm and PREVNAR13 lot#39679 Exp 10/31/2020 right arm at physicians 9/11 reported a rash that she thought was infected hair folicles on righ calf. Started on Triamcinilone cream and 10 day course of Amoxicillin. Over the next 2 weeks had more spots of rash, red, some raised on all extremities, buttocks, back and abdomen. Was given a steroid boost of 400MG and a punch biopsy performed which resulted in spongiotic dermatitis. Currently using baby AVENO to keep moist (OTC). Denies pain, denies drainage. Today rash on all extremities and back, abdomen, buttocks, chest. Differing shades of red, some raised, some appear scabbed. Has a follow up appointment schedule with DR on November 20, 2019
Hospitalized (12.4.21);  COVID-19 positive (12.4.21); fully vaccinated  Admission Date: 12/4/2021 Discharge Date: Dec 11, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Covid 19 pneumonia. HOSPITAL COURSE: PT is a 52 y.o. male with a PMH of type II DM, obesity, HLD, and GERD admitted for acute hypoxia secondary to COVID-19 pneumonia. He was vaccinated for COVID 19 infection. Symptoms started 10 days prior to admission. Positive test on 12/4.  The patient was treated with Decadron however was outside the therapeutic window for remdesivir.  His O2 requirements escalated quickly and his Decadron dosage was doubled from 6 mg to 12 mg. CT scan was negative for PE. HFNC started and pulmonology consulted. Pulmonology recommended monitoring on decadron and increasing to solumedrol if any worsening hypoxia. He was also started on Rocephin and Zithromax empirically for 5 days. Ultimately patient was able to be weaned to nasal cannula with continued slow improvement.  He completed the course of antibiotics and was transitioned from Decadron to prednisone 60 mg with plans for prolonged taper.   His A1C was very high at 12.2 and his blood sugars were difficult to control in setting of steroid use. RA was consulted and assisted in basal bolus insulin management.  The patient had reportedly never been on insulin however had been talking to his physicians about initiating it soon. RA recommended discharging on NPH 60 units daily, and to taper down to match the prednisone dosage. The patient received insulin administration and diabetic education during his hospitalization.  He was prescribed a glucometer for continue close monitoring.  He will need close follow-up with DGMS to discuss long term insulin plan.  He was evaluated by respiratory therapy who recommended discharge on 2 L nasal cannula continuously.  He was enrolled with the COVID at home program for continued close monitoring. The patient was discharged in stable condition.  Covid 19 pneumonia: Prednisone taper (60mg x 3 days, then decrease by 10mg every 3 days) prescribed at discharge. Pt evaluated by pulmonary rehab who recommends 2L/min continuously. The patient was enrolled in the Covid At Home Program for continued close monitoring.
This spontaneous report was received from a registered nurse and refers to 3 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M041990 and expiration date 28-SEP-2019 (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion from 9 to 25 degrees Celsius for 1 hour and 31 minutes. Data logger was involved. There were no previous excursions reported.
Entered hospital for cardiac catheterization.  Completed successfully with excellent report that heart had no blockages.  While in recovery, he became cold and began shaking uncontrollably.  Started complaining he could not breathe and lost consciousness.  Portable Chest xray showed large amount of fluid/congestion.  Fall in blood pressure.    Required intubation and placed on respirator.  Difficulty in maintaining blood pressure.  Transferred to Intensive Care Unit and remained on oxygen and respiration assist for almost 24 hours.  Given large intervenous doses of steroids and stabilize blood pressure.  Was it contrast?  was it vaccine?  No problem with contrast in past -- had CT with contrast 06/09/2022 with no problem
Was given the vaccine and about 5 minutes later started having swelling and my eyes and face.  It was watched for a few minutes and was assessed by EMS and taken to the emergency department.  I was given epinephrine, Benadryl,  Solu-Medrol, Pepcid, IV fluids, DuoNebs and observed overnight.  I  was given multiple rounds of Benadryl, steroids, Pepcid, DuoNebs
Initial information received on 26-Dec-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a six-months-old female patient who received 0.5 ml of third dose of vaccine PENTACEL (batch number: UI966AAA, expiry date: 7-Jul-2020) via intramuscular route in the right thigh on 26-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (FLU) for Immunization; ROTAVIRUS VACCINE for Immunization; and PREVNAR for Immunization. It was a case of actual medication error due to incorrect product storage (dose of PENTACEL was invalid due to shipping excursion). Caller stated that they received the shipment of PENTACEL vaccines on 21-Dec-2018 at 11:54 AM and it was in transit from 18-Dec-2018 at 15:39 PM. No adverse event was experienced. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
anthrax immunization 2 days ago now w/8cm x 12cm erythematous lesion to tricep, pruritus;tx w/DPH & motrin;
Localized swelling and redness immediately below injection site. Injection site seemed lower than usual, so unsure if reaction due to poor technique or vaccine. I notified the pharmacy with my concerns. Reddened area is firm-to-touch and appropriately 13 hours post injection. Some swelling a few hours after injection, but no redness until next morning. Area was sore-to-touch and upon moving arm. Reddened area was approximately half dollar in size.
She was dizzy for like the whole day; Vertigo; Low grade fever; Not thinking right# She was not acting normal; This is a spontaneous report. (CEP ID: 159558). A contactable consumer reported for a 93-year-old female patient (mother). A 93-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, NDC and UPC number: unknown), via an unspecified route of administration, administered in left arm on 05May2021 as single dose for COVID-19 immunization. The patient medical history included COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported.   On 06May2021 the patient experienced vertigo, low grade fever and not thinking right and she was not acting normal on 05May2021. She was dizzy for like the whole day on an unspecified date. It was reported that call was transferred. Transferring agent stated, patient have a caller on the other line and he was calling on behalf of his mother. So, his mother has the first dose of the vaccine on 05May however after the day of having first dose, his mother experienced vertigo all day and had a fever.  So, he mentioned as well that his mother was not thinking right but after a day or after that day she felt better and second dose appointment will be on 07Jun. So, he wanted to know if his mother can take second dose of the vaccine and want to talk more about the adverse event. Reporter stated, patient. She got infected with Covid in Jan (as patient had Covid before taking the vaccine, hence not captured as event). The day after the vaccine she developed a low grade fever and vertigo for the whole day and she was not acting normal the first day and for the day after 48hours later she was feeling back to normal. So, reporter question was should she get the second shot because she did not want to get the second shot. When paraphrased the concern, reporter stated, She got little bit fever and she had vertigo, she was dizzy for like the whole day. Reporter was informed about Pfizer Medical Information department and provided with the number. Reporter further stated, patient would have to repeat the same thing again. reporter don't understand you are in safety, you are expert. I need to speak with a medical doctor who can give me some information. reporter cannot be just transferred from one place to another. Reporter was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department. In response to further probing, reporter stated, No, reporter want to talk to someone please someone who have some feedback from all people getting the vaccine, let me call this other number. Further probing could not be done as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call.  The outcome of  events vertigo and low grade fever was recovered on 06May2021, whereas outcome for other events was unknown.  Information about lot/batch no has been requested.
Information has been received from a health care professional concerning a female patient who in approximately 1995 was vaccinated with VARVAX vaccine. In 1997 the patient developed a "mild case of chickenpox". No further details were provided.
Fever, onset 7 hours after injection, tachycardia, severe myalgias, arthralgias, HA, decreased appetite & sensitivity to light & sound. Present for 36-48 hrs after injection. Fatigue.
Patient was to be given Fluzone HD, but was given Pfizer Covid vaccine. Upon discovery of error, patient was informed of what had happened and patient opted to still receive Fluzone HD, which was then administered.  Patient was instructed to stay for 15 minutes for observation, in which time, no adverse events occurred.
Extreme myalgia and paresthsias, Pain 9/10. Similar presentation patient experienced with past meningitis event.  Insomnia, vision changes, agitation.  Prednisone is helpful in making pain bearable. Gabapentin started today. Labs pending.
Nausea x 4 days, concern that sx was r/t mild seizure activity.
pt went to school on 12FEB93 then Didn't feel well was lying down & had a sz; was seen in ER; t101.3, alert & oriented given APAP was comfortable & slept normally thru much of the ER visit; post DTP probable benign febrile seizure;
It hit me like a ton of bricks on Saturday, I felt feverish and had chills. By Sunday I felt like a truck had run over me. I was achy and wanted to sleep all. I took a home COVID-19 test Sunday evening that came back positive. On Monday morning I called my doctor and had a telehealth visit. I was prescribed Paxlovid that I started immediately and was feeling so much better by the end of the five days. My home COVID-19 test are coming back negative.
Upon assessing the patient it was discovered that he had a headache. He stated that his headache began approx 5 minutes after receiving his vaccination. Vital signs were then taken:  B/P: 118/80 Sat: 97% HR: 93 Temp: 97.3  When asked if he would like for 911 to be called the patient stated that his headache was feeling better and that he did not need a transport unit.
Worsening of mild, intermittent tinniutus to constant high-pitched loud tinnitus. Pressure in head and ears that comes and goes  (varies from day to day), waves of pins and needles through head and face (intermittent, daily), flushes of heat through body  (intermittent, most days of week).  Queasiness (most of the time), reduced appetite. The tinnitus manifested as a screech that sounds like it is in the head rather than  the ears, with lower frequencies that change in intensity in both ears.
Two days after the injection on 9-11-14 I experienced a mild swelling and itching of the injection site on my left arm, approx. 3 days after I felt very mild tingling sensation in my fingers on my left hand. Several days after that tingling started in my left toe. A week later, I noticed that I was hypersensitive to hot and cold water while I was washing my hands or taking a shower. A week later, I experienced confusion, minor muscle aches, twitching in my arms and legs. I experienced sleep tremors, approximately 1 month later, then other neuropathy symptoms which progressed. Question: I've noticed on the pharmacy sheet attached that most of the adverse reactions or side effects seem to suggest an immediate reaction after the shot. I do not know what arthralgia or myalgia are? Could these medical terms suggest neuropathy? And could they be a delayed reaction to a shingles shot? Please do not contact anyone from the medical profession concerning this letter. And please answer the question above concerning neuropathy. I can be reached if you have any additional questions.
Crying for 3 hours, after vaccine, began after vaccine administered for 6 hours. Only reported at the 4 month visit.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
3/4/18 Pt went to E.D. for complex febrile seizure. EEG done no abnormalities.
Itching on neck, rash on both sides of neck, welt over collarbone area on skin.
PATIENT CALLED ON 10/15, SAID SHE GOT REDNESS, BURNING SENSATION 3 TO 4 INCH BELOW SHOULDER UP TO ELBOW AND AROUND CHEEKS. SHE FEELS HOT AT THAT AREA.
Right - RIGHT KNEE REPLACEMENT - Patient did well post operative. No issues with the patients hospital stay.  Pain and subsequent slow progress, requiring more rehab and dilaudid to control pain.  Hospital admission within 6 weeks of receiving the COVID vaccine.
Left knee swollen, Atarax/Benadryl, 1tsp every 6 -8 hrs.
1st shot 8/11/2021 2nd shot 9/3/2021  24 hours after the 2nd shot swollen lymph node under left armpit.  7 days later a red and swollen lump under the right breast tissue.  This lymph/ node or lump was swollen, tender, painful and red.  Doctor diagnosed and treated with antibiotics on 9/12/21 for possible mastitis infection of right breast post vaccination.
patient got the flu; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).   This case involves patient [age and gender unspecified] who got the flu, while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient  got the flu shot for 15 years and got the flu every year. Patient haven't got flu for 30 years.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Patient had an injection site reaction. Patient reported pain with swelling and redness severe enough they were treated at the emergency room for the discomfort.
Red, Raised approx. 6 inches. area to left upper arm. Donor C/O Soreness and itching, area warm to touch
Mother came into clinic 10/9/02 with child and reported that she had taken her toddler to the hospital ER for treatment for his right erythematous thigh. Hospital administered Benadryl. He was taken there 10/6/02 after she noticed the red thigh.
COVID-19  Encounter for screening laboratory testing for COVID-19 virus  BMI 26.0-26.9,adult
This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot #: L044526, expiration date on 09-NOV-2017; lot #: L049535, expiration date on 18-DEC-2017 and lot #: L048468, expiration date on 02-DEC-2017 (dose number, strength and anatomical location were not provided). The vaccines were stored in a temperature of 6F during 72 hours. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Whole body hurts and standing up is difficult for more than 10 minutes. Right side of body is in a lot of pain and I can?t hold anything up