chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 70 years old female patient. The patient was vaccinated with ZOSTAVAX on 09-OCT-2012, subcutaneously in the left arm (dose and Lot # were not reported). No other co-suspects were reported. No concomitant medications were reported. At the end of October 2012 (reported as "in the last few days") the patient developed persisting, tingling left arm pain radiating to the fingers. The patient has noticed decreased grip strength in the left hand. No treatment was provided for the AEs. The outcome of decreased grip strength in the left hand, has developed persistent, tingling left arm pain radiating to the fingers, decreased grip strength in the left hand and tingling left arm was not reported for ZOSTAVAX. Additional information has been requested.
Vesiculobullous Rash - Information has been received from a physican's office concerning a 7 year old caucasian female patient who on 26 May 1999 was vaccinated sc in the left arm with one dose of varicella virus vaccine live (lot 629163/0308J) On 02 apr 2000 the patient experienced a vasicular rash.  It was noted that the patient had no recent  varicella exposure.  On 03 Apr 2000 the patient was seen by a physican . A swab of lesion was obtained to rule out varicella.  follow up information reported that DFA and culture for herpes simplex and varicella zoster virus were obtained.  Preliminary isolation was negative at 24 hours on 06 Apr 2000 and negative at 48 hours on 07 Apr 2000.  Final isolation result was negative at 96 hours.  The DFA result on 10 Apr 2000 revealed too few cells for reliable interpretation.
Vial containing concentrated vaccine was not diluted prior to administration. Patient received dose similar to concentration of adult dose. Advised patient's mother to monitor closely for side effects and to follow up with pediatrician or emergency room if needed. Attempted to follow up with patient's mother a few days following the event, but was unable to reach her. Left her a voicemail, but she has not returned the call.
Patient called the pharmacy today stating that she started having a reaction the day after receiving her pneumonia shot. Patient reports she started having swelling in the face and around eyes the day after her vaccination. Patient received Prevnar 20 on 6/16/2022 and started having symptoms then evening of 2/17/2022. Patient also started meloxicam on 2/17/2022.
on 1/12  symptoms experienced : temp99.5-99.8, Shivering Chills, chills, body aches, headache nausea , vomitingx4 and fatigue
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was vaccinated with ROTATEQ (lot number and dosage were not known) orally on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient received ROTATEQ and spitted up right after the dose was administered. No adverse event report. The outcome was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Hot, hive like redness size of grapefruit; itching; low grade headache. Treated with ice pack; Benadryl; Cortisone cream. As of 7/14/2015 redness and itching continue but not as bad.
Behavior issues since receiving H1N1. Received the H1N1 vaccine during clinic on Wednesday. That afternoon mom and MGM noticed a distinct change in her behavior that continues today. She is not listening, she is not sleeping well, and she is acting like she has absolutely no control over her hyperactivity. Mom isn't overly concerned, but she doesn't think it's something acute and she truly thinks that the FLU MIST is causing her to act this way. Something similar happened a couple of years ago when she tried CLARITIN and it took about 3 or 4 days, but mom realized that the CLARITIN was causing a change in her behavior.
pt recv vax 10SEP96 & 5MAR97 pt devel chickenpox;pt was seen by MD on 8MAR97 w/approx 10 spots described as mostly clear blisters & some red spots w/o a blister;
Very sore throat; Chills; Severe exhaustion; Nausea; Fever; Joint pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included mental illness. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valproate semisodium (DEPAKOTE), quetiapine fumarate (SEROQUEL), lurasidone hydrochloride (LATUDA), propranolol (MANUFACTURER UNKNOWN) and clonazepam (KLONOPIN), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 14:45, the patient experienced very sore throat, chills, severe exhaustion, nausea, fever and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events very sore throat, chills, severe exhaustion, nausea, fever and joint pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician via company representative refers to a 13 year old female patient. On 14-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (dose 1, 0.5 ml, intramuscular in the right arm, lot # and expiration date not reported). Concomitant medications, pertinent medical history and drug reactions/allergies were not reported. The reporter stated that the patient was nervous about getting her first dose of GARDASIL and was breathing heavy. On 14-JUL-2014, 30 seconds after being vaccinated, the patient fainted, and then 5 seconds after the patient had Tonic-clonic seizure. The patient also passed urine (elapsed time reported as immediately thereafter). The outcome of the adverse events was unknown. Causality assessment was not provided by the reporter. Upon internal review, tonic-clonic seizure was considered as medically significant. Additional information has been requested.
Currently pregnant due May 31. I got the vaccine at 4 pm on Wednesday. At around 6pm I started to get a headache, I took 2 tylenol but it continued to get progressively worse. By 7 I was starting to get really fatigued and fell asleep. I woke up around 8 or 9 still fatigued with body aches and a headache. The body aches and headache continued to worsen, but due to pregnancy I could not take any more tylenol. Around midnight I got out of bed to use the bathroom and immediately started violently shivering. It continued for a few minutes after I got back into bed, it did cause a lot of pain in my joints and muscles. A few hours later I woke up very hot and sweaty. The next day (Thursday) I continued to feel very fatigued with body aches and a headache to the point where I had to stop working even though I work from home. The following day (Friday) I was still mildly fatigued and had some body aches, and my brain felt very foggy so I took off work again. I regularly checked my temperature during this time and did not have a fever.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), calcium salt (Calcium Unknown), simvastatin, vitamin d and cetirizine hydrochloride (Zyrtec). On 25th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, lethargy, fever, myalgia and shivering. On 26th April 2018, the outcome of the headache and lethargy were recovered/resolved. On 12th July 2018, the outcome of the injection site pain, fever and myalgia were recovered/resolved. On an unknown date, the outcome of the shivering was recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, lethargy, fever, myalgia and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left arm. The patient planned to continue follow-up with her physician on an unknown date. For the tolerability of 2nd dose, refer case US2018GSK135622 reported for same patient.
4/5/21 @ 10:30pm. Severe chills, body aches, headache, sweating, nausea, dizziness, extreme exhaustion.  Lasted for 36 hours.
Immediately upon receiving the vaccine I felt weird.  Lightheadedness and tightening of jaw.  Clenching of my teeth, even though I was not trying to do so.  At times, I almost had to remind myself to breath.  It was very odd.  I checked my 02 when I got home and it was normal. These symptoms lingered for at least 3 hours.  It then turned to stomach pain and nausea, which lasted 24 hours.  Have had diarrhea off and on since vaccine.  On Monday (3 days post vaccine) I started having severe heart pain, which resolved the following day.  That same day (4 days post vaccine)  my most serious symptom appeared which would be swollen lymph node in my left armpit (injection arm).  That lingers now a week after onset, is painful, and impairs mobility in my arm.  My glands in my throat/neck area became swollen around this time as well, and continue to swell off and on.  I am now at post-vaccine Day 11.
Received Gardasil, Menactra and Tdap 7/12/07 at 9am - patient felt dizzy in parking lot - was fine then the evening. Woke at 4am with chills, not able to speak a full sentence, fever 104, mom felt she was delirious, c/o tingling of her fingers and muscle aches. Patient later told mom she felt as of her throat was closing in the am. Patient was fine according to mom.
Extreme stomach issues (nausea vomiting and weight loss of 20 pounds over next month following doses) and got perianal colitis that resulted in an anal abscess; more frequent and heavy periods since first rounds of covid shots that have not stopped in frequency or heavy bleeding (huge clots and periods twice a month now); also low appetite and lots of weird stomach pains; the short term but still concerning side effects are increased tsh levels a few weeks after my second shot of moderna; a rapid heart rate and weird heart flutters after the first few days then extremely tired for a month after each dose. I feel like my physical health has changed for the worse in some ways after this booster and get more frequent skin infections; losing more hair; dizziness; and extreme issues with mental health being greatly reduced after each dose of moderna as well. Brain fog and zaps. Weakness in body at times. I did not have these before the shots or booster or at the same intensity with the skin infections.
Information has been received from an office manager concerning a 63 year old male consumer who in July 2007, was vaccinated SQ with a single dose vial of zoster vaccine live (Oka/Merck). Subsequently, in August 2007 the patient developed shingles. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
I was paralyzed; the vaccine gave me guillain-barre; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration on 03Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient was paralyzed and hospitalised for 11 days and then in rehab for 5 days. The patient also experienced medically significant Guillain-Barre syndrome. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
sore arm after first dose of the vaccine; This is a spontaneous report received from a contactable consumer. The reporter is the parent.  A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm after first dose of the vaccine". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The first dose was administered 3 weeks prior (as reported). The reporter stated that with the first one, his arm was sore the day he got the vaccine and then the day after he was fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain woke her up at 3am and she could not sleep; Pain in arm.Could not move her arm out from her body; shoulder was "killing" her.cannot move her shoulder as it hurts; This spontaneous case was reported by an other and describes the occurrence of ARTHRALGIA (shoulder was "killing" her.cannot move her shoulder as it hurts), INSOMNIA (pain woke her up at 3am and she could not sleep) and PAIN IN EXTREMITY (Pain in arm.Could not move her arm out from her body) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included no adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ARTHRALGIA (shoulder was "killing" her.cannot move her shoulder as it hurts). On 06-Apr-2021, the patient experienced INSOMNIA (pain woke her up at 3am and she could not sleep) and PAIN IN EXTREMITY (Pain in arm.Could not move her arm out from her body). The patient was treated with IBUPROFEN on 05-Apr-2021 for Pain, at a dose of 600 mg once a day. At the time of the report, ARTHRALGIA (shoulder was "killing" her.cannot move her shoulder as it hurts), INSOMNIA (pain woke her up at 3am and she could not sleep) and PAIN IN EXTREMITY (Pain in arm.Could not move her arm out from her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.
Client reports tongue and throat swollen. Slight difficulty breathing. White spots in back of throat. Client took one Benadryl with no effect and then took 2 more Benadryl 1 hour later. Reports tiredness and fatigue, overall body aches. client reports sleeping for 10 hours. This morning symptoms of tongue swelling ,"not as bad as yesterday, but still swollen", and "breathing is not that bad" per client. Otherwise unchanged and client took 1 more Benadryl this morning 2/1/2017. Referred client to an Urgent Care or primary doctor. Advised some side effects could possibly be from vaccines or possibly from other sources. Also advised if she were truly having difficulty breathing to call 911.
I had vertigo and dizziness on the morning of 11/12/2021 08:00am. I also had pain, itching and swelling lump closer to lower bicep on my left arm, but not on the injection site.
Grandmother fell in parking lot while carrying child from immunize clinic, reportedly falling on this 2 mos old infant. Grandmother and infant seen in ER. Mother of child states child had a "splotchy red rash on her chest" within 5-10 mins after immun. We did not know about rash until mom brought child in for 2nd set of immunizations and told us that infant "had a reaction to her first shots given at health dept."
I got my first covid vaccine on 5/4/2021 on my left arm. After getting the vaccine I had soreness in my arm, chills, fatigue, and sore throat for about  week after the first shot. On 5/13/2021 I noticed a huge lump about the size of an egg near my left collarbone along with pain and soreness going all up my neck on the left side. I went to the ER about the lump where they did bloodwork and a CAT scan and concluded the lump was a swollen lymph node. I cannot remember if this symptom was happening before the ER visit, but I do know for a fact my left thumb was twitching at least the day after the ER visit. I believe I could have been ignoring the twitching at first thinking it was just a radom muscle spasm that is why I did not mention it to the doctor when I went to the ER. It continued to twitch for several seconds every few minutes for 2 weeks and only in the last few days has the twitching slowed down. Now it happens several times every hour or so.  I decided when I got the second vaccine today (06/02/2021) to get it in the opposite right arm. So far symptoms other than my left thumb twitching and lymph nodes still being swollen are soreness in the right arm, and tiredness/fatigue.
given flublok for 18 years of age and older instead of fluzone for 18 years of age and younger
Bell's Palsy; shingles; This case was reported by a consumer and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the bell's palsy and shingles were unknown.   It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Bells palsy and had shingles 2 times post vaccination. The patient asked if anyone had the shot and still had shingles. The patient stated that he/she was not told anything about needing the 2nd shot.
Much increased sensitivity to spicy and high temperature food. Have never experienced this before.  Even just onions or black pepper now hard to tolerate.  Not a debilitating problem, interesting as one who has always enjoyed hot/spicy food.
on 2.15.2021 Pt stated c itching + Rash and she took benadryl and on 2/16/2021 she notice the rash worsening + lip swelling,  she went to ER and was given epinephrine
REDNESS, SWOLLEN, AND PAINFUL HOURS AFTER INJECTION. IS  IMPROVING 2 DAYS LATER
3" x 4" inch induration on left thigh warm to touch, no itchy. Treatment with Benadryl, Ibuprofen, Claritin.
developed Shingles in early September; developed Shingles in early September; rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2020, between 10 and 12 months after receiving Shingrix and between 7 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On 1st October 2020, the outcome of the vaccination failure was not recovered/not resolved. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient developed Shingles in early September and that it had not resolved till the time of reporting. He followed up with his dermatologist and was prescribed some cream to apply to the rash. The reporter consented to follow up
Got two-shot regimen, have shingles/ Suspected vaccination failure; Shingles on head, face; worst Pain, agony; Numbness; Strange sensations on head, face; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immune system disorder.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, numbness and feeling abnormal. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles, numbness and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, numbness and feeling abnormal to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got both old and more recent two shot regimen and still currently had shingles on head and face.  The patient had low immune system plus they say 90 out of 100 would not have shingles. It was the worst pain and agony. It had been going on 3months and still had numbness and strange sensations running through patients head and face. The reporter reported that take the shots as per as possible. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I received my COVID 19 Booster shot and my flu shot together.  A day later I began to experience frequent PVCs and PACs with my heart. I contacted my cardiologist and wore a halter monitor for two days to measure the events. I experienced over 11,000 PVCs within the two days (or 4.64% of my heart beats were abnormal). I followed up by receiving a echocardiogram.  The doctor placed me on a magnesium supplement and told me to continue to eat a high in magnesium diet. The PVCS were frequent for about a month and a half
No additional AE/No adverse effects reported; HCP called to report inadvertent administration of an expired dose of MMR II.  Dose expired on 4/15/2023, and was administered today (4/17/2023). No adverse effects reported.  No additional AE/No PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified demographics . There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-APR-2023, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (M-M-R II) injection, 0.5 mL, lot# U011993 with expiration date 15-APR-2023 (dose number, frequency, route and site of administration were not reported) for prophylaxis (expired product administered). No adverse effects were reported (no adverse event).