chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the above vaccine 2nd dose one year later as recommended, the first was the Prevnar 13(10/19/2020.. .A couple hours after receiving the  PPSV23 vaccine, my right arm and surrounding area , increasing pain in that surrounding areas and could barley lift my arm ( used the other arm to assist the right arm, to avoid  more  pain. then after about 8 hours the pain started to slowly decreased daily, by the third day still was soreness in the are of the shot. As days went on, at times I could feel sensation at the spot where the vaccine was given, a slight soreness.   Was this an actually adverse reaction or was it because of poor technique giving them IM shot and done given properly? I only  had pain at the site area as stated above, no fever, no other symptoms to be aware of that was different. I was able to squeeze and make a fist.  The strength in the arm was normal. No swelling, no redness, I tried heating a pad and took a Motrin (did not have any Tylenol-maybe this help some what.
This case was reported by a consumer via sales rep and described the occurrence of lethargy in a female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose, (refer case US2018GSK183150)). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced lethargy and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the lethargy and pain were unknown. It was unknown if the reporter considered the lethargy and pain to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced no fever but lethargic and achy. The reporter did agree to be contacted for follow up information.
Very anxious before vaccine; BP at home 154/90.  Felt like "punched in face"/foggy; lightheaded. BP 148/98; pulse 88; p ox 98%; gave water. Continued monitoring; after about 30 minutes, then noted chest "heaviness"; "sore throat"--no tightness, no vision changes. Rapid response evaluated; Patient refused ED; continued monitoring for 10-15. VSS; chest heaviness resolved. Accompanied to hospital entrance; had ride home.
Chills/chills in the night; Headache, very severe headache very painful; Pain at the injection site; Little bit of stomach cramping and pain; probably a fever too; Little pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 at single dose for Covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced chills, headache, very severe headache very painful, pain at the injection site, little bit of stomach cramping and pain and probably a fever too, little pain and chills in the night in Dec2020. The outcome of the events was unknown.
HYPOTENSION 9/26/2022 CKD STAGE 4 (GFR 15-29)
Red, hard rash around injection site,  muscular pain left arm, diarrhea, fatigue
Patient developed acute onset of poor feeding on 1/10/23.  Started vomiting on 1/11/23 and was diagnosed with Intussusception on 1/11/23.  Intussusception was successfully reduced with barium enema in the hospital. F/U US was normal. Infant is doing well currently and feeding normally.
On 3-22 11 days after vaccination), patient presented with lower extremity weakness and uper extremity paresthesias
Left side of face is puffy, swollen, and tight; Left side of face is puffy, swollen, and tight; Tightness in left eye/eyebrow, lip, nose, and cheek; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), first dose via an unspecified route of administration, administered in left arm on 08Mar2021 at 18:15 (at the age of 65-year-old) as dose 1, single for COVID-19 immunisation at hospital. No medical history was reported (Caller stated she never had the measles, chicken pox, none of that stuff. She was a healthy kid. Caller mentioned she almost did not get the Covid shot but her mom convinced her to. She got it because she does not want to expose anyone or anyone to expose her). No Family Medical History Relevant to adverse events was reported. There were no concomitant medications. No investigation assessment was reported. No vaccine was administered at facility. No previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Caller stated she never had a flu shot, nothing. No adverse event following prior vaccinations. On 11Mar2021 at 05:00, the patient experienced left side of face is puffy, swollen, and tight, tightness in left eye/eyebrow, lip, nose, and cheek. It was reported that, this morning (on 11Mar2021 at 05:00) when she woke up, the whole left side of her face was puffy, swollen, and tight. Caller clarified she felt tightness in her left eye/eyebrow, lip, nose, and cheek. Caller described it looks like she has food stuck in one side of her mouth. Caller reported she can feel it and see it too; it's not bad but she can see the difference. Caller reported she did not go to the doctor's, but she did call the doctor. Caller reported she does not know if it was necessary to see the doctor because it was not painful. Caller stated she noticed it when she got up to walk her dog this morning at about 05:00. Caller stated that she guesses her events are persisting, it was getting a little bigger, it was not painful, but it was tight. It was the same as it has been, but it was noticeable. Caller was scheduled to go back 29Mar2021 for her second dose. Caller stated that she was pretty healthy. No adverse event required a visit to emergency room or physician office. No Relevant Tests were performed. The outcome of the events was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
metallic taste in mouth , "heatness under skin" , high blood pressure  also took magnesium after getting vaccine
Headache, Myalgia & Arthralgia Narrative:  severe headache, body/join aches, fatigue, chills, pain at injections site, unable to work due to incapacitation on 1/26/2021
Beginning 08/11/2005 pain from shoulder to elbow, reports spotty bruise below elbow pain continues through today 08/23/2005 worse at night.
previous flu shot 3 did not work; Initial information received on 03-Oct-2021 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who reported did not work (vaccination failure) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past 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 and reported (unknown latency) did not work (vaccination failure).  This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.; Sender's Comments: This case concerns an unknown demographic patient who reported did not work after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, there is no information regarding patient's condition at time of vaccination, immune status, vaccination details, event details and lab test confirming diagnosis or excluding alternate etiology. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
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 an unknown date in 2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, 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. On an unknown date in 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Arm was sore,Body Aches; Arm was sore,Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02FB21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches). On 10-Apr-2021, MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-355605 (Patient Link).
Redness and swelling with warmth on Left arm.  Hard and raised at the site.  No fever.
About 10-15 minutes after receiving the injection while grocery shopping next door to the pharmacy where I received the injection I suddenly felt odd and slightly dizzy. I looked at my watch that I was wearing and my heart rate was 194 beats per minute, I confirmed this rate by taking my pulse manually too. Needless to say, that was a very high heart rate especially when not exercising at the time. After observing that my heart rate was staying in the 184-194 range for 10 minutes, I drove myself to the hospital emergency room but they were very busy and I was told to have a seat and wait despite my heart rate at 186. After about 10 minutes of waiting in the emergency room waiting room my heart rate suddenly dropped down to 114 beats per minute. After about 5 more minutes of observing my heart rate on my watch as being normal, I chose to leave the emergency waiting room since the elevated heart rate event was over. I do have the graph of it on the Cardiogram app. Since then, all has been fine.
HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES 6/28-7/4/2022
Called  immunization line and left message. Called client back. Complaining of generally not feeling well;  extremely dizzy; HA; nausea; vomiting; diarrhea on 1-8-2021
"Moderna COVID-19 vaccine," Patient received 0.5ml instead of 0.25ml COVID booster dose.
skin rash (redness, bumps), itchiness on both arm, the left side is more severe than the right side. it happened about one and half week after getting the shot. and it has been last for more than one month. (got vaccine on 2/17/19) (patient came in on 4/27/19 to show me the rash, I advised patient to get medical attention from the doctor)
Patient fully vaccinated. 8/10/21- sore throat, exposure four days prior to a positive covid case. 8/13/21, tested positive for Covid
Pt was given Pfizer vaccine at 1254 pm in right deltoid , went to observation and began experiencing numbness and tingling at 100pm. Assessed by nursing staff 121/70. Pt experiencing slurred speech. 911 called at 106pm, arrived at 115pm. 111pm VS: 136/83, 888 pox:99%. Paramedics here transported to ER at 118pm.
This report describes neuropathy in a male vaccinee of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). The vaccine's medical history, concurrent medications and concurrent medications were not specified. The vaccinee received his first and second injections of Lymerix without adverse event. In 05/2000, he received his third injection of Lymerix. the reporting rheumatologist stated that it was reported to her that the patient developed neuropathy and numbness "soon after" the third injection of Lymerix; however, she did not see the patient until 15 months later. As of 04/30/02, the events persisted. The adverse event 'neuropathy" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter.
Fever started about 12 hours after 2nd vaccine. Lasted for a few hours before breaking. Felt achy nd extremely weak for about a day and then symptoms subsided.
This case was reported in a literature article and described the occurrence of seizure in a infant unk subject who received Flu seasonal TIV Dresden. On an unknown date, less than a week after receiving Flu seasonal TIV Dresden, the subject developed seizure. Serious criteria included GSK medically significant. The outcome of seizure was unknown. The investigator considered that there was a reasonable possibility that the seizure may have been caused by Flu seasonal TIV Dresden. Additional information received: This case was reported in a literature article and it described the occurrence of seizures in a child of unspecified gender between 6 and 59 months of age who had received an unspecified trivalent vaccine (manufacturers unknown). This case was identified after searching a large insurer database for medical claims. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date in the 2010-2011 influenza season, the patient received at least 1 dose of an unspecified trivalent vaccine (dosage, administration route and site unknown; batch number not provided). On an unspecified date, either the day of the vaccine administration or the following day, the patient suffered seizures. The diagnosis was confirmed by the authors after reviewing the patient's medical records. Treatment was unknown. The outcome of the event was unspecified at the time of reporting. The authors commented that the event had been temporarily associated with seasonal influenza vaccine previously. The authors concluded that "we utilized a claims-based data source to evaluate the safety of trivalent influenza vaccines and H1N1 vaccines. We ultimately found no increased outcome risk following 998,881 trivalent influenza vaccines and 538,257 H1N1 vaccine doses administered in the 2009-2010 season, and 1,158,932 trivalent influenza vaccine doses in the 2010-2011 season. The large number of vaccines in this health plans' database allowed for precise risk estimates of most outcomes, although claims profile reviews were critical in excluding cases with alternate explanations. This study adds to the body of evidence supporting the safety of influenza vaccines". This case is 1 of the 3 valid cases reported in the same literature article (see case US2015GSK116277).
4 months after receiving Moderna shot I came down with an ear infection which lasted 6 weeks. I visited providers 3 times and eventually visited an ENT  Received a booster on 11/10 and 2 months later had a second more intense ear infection
Client c/o feeling drunk and very hot. Vital were take in was within normal limits and client began to state that she had numbness in her legs  and was very hot.  I then placed an ice pack on her neck (rear) and forehead. But, when I asked about 10 minutes later she stated that she felt better and was thirsty. I did give her a sip of water to evaluate her swallowing (sip) which was done with no complication.  When she stood for me to evaluate her gait she c/o numbness and tingling and both legs. So, I had her sit down for about 10-15 minutes and re-evaluated. She stated that her legs felt better so the vital were taken again and were still with in normal limits. So I was discharging the client and she did self ambulate to the vehicle where her friend was to drive her home.  When we arrive at the car she just was not walking with a steady gait and said her legs were numb: so I had she sit and after re-evaluating I decided to call EMS to evaluate her and maybe transport her to the hospital . When EMS arrived and checked her out the client refused to be transported to the hospital. But EMS did say that her vitals were normal and no distress was present. So, I monitored her after the paramedics left and no distress was presented.  She said her legs were feeling better and she did ambulate to the ambulance and back to the car with no incident. So I discharged her to her friend to drive home. I called her a few hour later and she said that she felt much better and the numbness was in the right leg only. Safety was maintained throughout the occurrence and her breathing was never comprised.
Patient fell in parking lot after leaving the vaccine clinic, she was caught by another person. she has a history of vertigo. she was monitored for an additional 30-45 minutes. Her blood pressure was taken several times, and gave patient water.
On 04/02/2002 telephone call received from client complaining of "tingling sensation arm and shoulder, hands, fever (100 deg. F), nausea, onset developed approximately 1 hour after vaccine administration."
This is a spontaneous report from a contactable office manager calling on behalf of a physician. The office manager reported similar events for 3 patients. This is the 2nd of 3 reports. A female patient of an unspecified age received PREVNAR 13 (LOT R19477; expiration Jan2018) via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced local swelling and arm pain. The outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017129381 same reporter/drug, different patient.
Received "Flu Mist" via nose on Jan 8, 2005.  After about 24 hours, began flu-like symptoms.  After 2 days, more significant flu-like symptoms (fever, chills, aches, etc.)  After 3 days, very significant symptoms causing loss of work.
On 03/31/2021 about 2PM I started feeling tired and had chills, nausea. I had a fever of 103, and a headache that lasted for five days. I called the doctor and he said to take Motrin and Tylenol. I felt awful for about 24 hours.
HIGH TROPONINS; CHEST PAINS; PRODUCT WAS NOT PROPERLY STORED FROM RECEIPT TO ADMINISTRATION(PRODUCT STORAGE ERROR); This spontaneous report received from a patient via a company representative concerned a male 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: Unknown, Expiry Date: UNKNOWN) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-APR-2021, the patient went to emergency room for pains in the chest on same day the patient was admitted overnight in hospital due to high level of troponins. The patient might got catheterized. It was also stated that product was not properly stored from receipt to administration (product storage error). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pains, high troponins and product was not properly stored from receipt to administration (product storage error) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210431465-Covid-19 vaccine ad26.cov2.s-Chest pain and high troponin .This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
pts daughter stated ear lobes were red, he had low grade fever and left arm was warm to touch about 3" below injection site the day after the vaccine.  Next day after the arm was increasingly turning more red.  On 1/12/2021 the pt went to the ER clinic and was diagnosed w/ cellulitis on left arm.  Pt is now recovered from this after being treated w/ antibiotics.
I got ill after 7 days . after my 2nd shot! swelling and hard to breath
headaches, coughing, fatigue, fever, chills, nonapeptide, vomiting
Child began running fever after vaccinations. At approximately 1830 child began having seizure like activity. Parent took to ED immediately, when temp check rectally it was 104.7. Was given MOTRIN. Parents state seizure lasted around 5 mins.
9/17/2020- Fever 9/18/2020- Intense watery diarrhea, abdominal pain, fever 9/19/2020- Called ER and reported continued symptoms above. Nurse in ER advises an antidiarrheal be taken. Patient follows instructions with no relief. 09/20/2020- Symptoms continue and patient goes to ER in the morning. Dr. evaluates and tells patient he does not believe the symptoms are vaccine related. Gives IV fluids for dehydration and prescribes oral medication for gastro symptoms.  09/22/2020- Patient feels fully recovered from illness.
pt recv adolescent dose of vax instead of infant dose 30JUN97 & pt exp inc irritability & presented to an ER w/a local rxn to vax;1JUL97 pt recovered;
INITIAL VACCINE JANSSEN 3/31/2021 SECOND VACCINE MODERNA 4/7/2021 (ONE WEEK LATER) THIRD VACCINE MODERNA 5/15/2021
arm soreness; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 63 years or 64 years. The patient received Shingrix in the left arm. The patient now experiencing headache and arm soreness.   The patient called seeking recommendation of what to take for the symptoms. The patient was referred to her physician. The reporter declined DOB and providing phone number.
Achy arm and sore to touch; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 16 year-old male patient received meningococcal group b rlp2086 (TRUMENBA) (Batch/Lot number: unknown) as dose 2, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Trumenba (1st Dose), for immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Achy arm and sore to touch". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.