chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; Blister; Nerve pain has gotten worse; Nerve pain was better with vaccine series; an episode of Shingles/Suspected vaccination failure; an episode of Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included nerve pain. Concomitant products included medication unknown (Other Medications) and gabapentin.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). In JAN-2022, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: an episode of Shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: an episode of Shingles). On an unknown date, the patient experienced rash (Verbatim: rash), blister (Verbatim: Blister), condition aggravated (Verbatim: Nerve pain has gotten worse) and unexpected therapeutic effect (Verbatim: Nerve pain was better with vaccine series). The outcome of the vaccination failure and unexpected therapeutic effect were unknown and the outcome of the shingles was not reported and the outcome of the rash and blister were recovered/resolved and the outcome of the condition aggravated was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, blister and condition aggravated to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, rash, blister and condition aggravated to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023AMR041942   Additional Information: GSK Receipt Date: 16-MAR-2023 The reporter stated that she had an episode of Shingles. The patient reported that the rash and blisters had resolved. Patient reports that the nerve pain was better when she got her Shingrix vaccine series (dose 1 and dose 2). The patient reported that she was prescribed Gabapentin for the nerve pain, but it did not helped with the pain.  The patient reported that she took other medications in addition to Gabapentin for other medical conditions.  The patient did not recall the dates of the vaccination.  The patient did not recall in which arm she was administered the vaccines.  The patient stated that she could obtain this information from the pharmacy where she got vaccinated. The patient stated that she did not had rash or blisters, but the nerve pain had gotten worse.  The patient reported the nerve pain was worse than when she got the vaccines. Not all information is available.  The patient provided consent to follow up with health care professional (HCP). This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
9 cm roughly circular red/warm/itching raised patch surrounding injection site. Few clear vesicles (central ) noted started less than 24 hrs after injection
devel fever, chills w/in 8-10 hrs of inject; adenopathy; abscess @ site of inject (sterile) requiring drainage; total time of illness 3 1/2 wks;
Pt stated she received vaccine on 2/4/08. About 4 days later she had a Herpes Simplex breakout in her mouth. It started by her molars and went to her ear and into her sinuses. Pt has a history of this and has been prescribed Acyclovir 200mg. She started taking the Acyclovir after the Herpes Simplex breakout started and it has since resolved. Pt is concerned that the vaccine caused the Herpes Simplex breakout.
1) Immediately noticed that I was light-headed or dizzy upon receiving shot.  2) My face started to feel numb on the left side (below the eye to the jawline and from below my left ear to my nose area. I was worried about a stroke, so I made sure that I was able to smile in my rear-view mirror. The numbness began to clear up around 8 hours later without any muscular drooping of eye or mouth. I still have tingling or a numb feeling in areas but it is not significant at this time.  3) fatigue, slight nausea, pain in right collar bone area has been present since Monday. All seem to be minor side effects.
I started to get mild nausea within about 15 mins.   then a chemical taste in my mouth.     Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge.   During the night I woke up because the phlegm was much worse and abundant    I wanted to sleep so at first was swallowing it,  then it was so much that I got up and went to the bathroom.  That is when I noticed that the palms of my hands were scarlet red.  on both hands and not on the wrists or any where else.    by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach.   Yesterday , 3 days later,  still had diarrhea and nausea and was tired,,symptoms are not severe,   but since these are not typical symptoms for me.   I figured they will go away,  but also I figured that I should communicate the reaction .   I am scheduled for my 2nd shot in 3 weeks,
Elevated Immune System Response; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration, in the left arm on 17Mar2021 at 10:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported and did not have allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not test positive for COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID) 125 mg from unknown dates for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 02:00, the patient experienced elevated immune system response. The patient did not receive any treatment for the event elevated immune system response. The clinical outcome of the event elevated immune system response (therapeutic response increased) was not resolved.   No follow-up attempts are needed. No further information is expected.
initial dose, shingles within a week; This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. The action taken with Shingrix was unknown (Dechallenge was unknown). Rechallenge with Shingrix was unknown. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information reported are as follow: The reporter stated that the patient had experienced Shingles within a week after administration of first dose of Shingrix. The reporter consented to follow up.
Narrative: temp of 101.3 drop to 100.4 and normalized to  98.7 within 1 hour without any interventions or treatments.
Received shot on 11-7-08 around 1:00pm and on 11-10-08 so dizzy, could not stand, perfuse sweating, could not stand without help and unable to walk to bed, sharp pains in knee, elbow joints, wrist, shoulders.  Very very weak, still very tired feeling worse with soar throat and on 11-10-08 - When onset felt nauseous when moving.  Hard to concentrate, still weak.
tgeybhad the flu; Initial information regarding an unsolicited valid non-serious case received from a non health care professional via social media on 06-DEC-2020 This case involves a patient of unknown age and gender who reported tgeybhad the flu (Influenza), while he/she received vaccine Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter reported that then explain to why a couple I worked with got Flu shot every year and by the end odbtge week tgeybhad the flu. They then decided not to get the flu shot guess what they Dident get the flu that year or the following years.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
3-4 small autoinoculation lesions (2-3mm) on left forearm and left shoulder with very vigorous  primary vaccine response.
Moderna COVID-19 Vaccine EUA 1 week after note red circle around injection site 3 inch by 2 inch, no pain or tenderness noted. Only other symptoms was sore arm for 48 hours after injection
Difficulty walking, achy legs, very heavy legs, lightheaded, feeling like I have a concussion, headaches front and back of head, disoriented, brain fog, exhausted, shaky, weak, watery eyes
Dizzy, feeling faint. Placed cold rag on back of her neck, got cold beverage, placed at bench that has arms on either side.
RA was relatively controlled at time of 1st (3/30/21) and 2nd (4/21/21) vaccines (3/22/21 Sed Rate 25; CRP 24.6).  Initially no discomfort, feeling like flu, or any adverse reaction.  On 2nd day, I woke up with my joints so stiff I was not able to move freely; I had to start with moving my fingers, then to wrist, then elbow, shoulder, etc.  I continued to have a flare up severe enough I could not walk unaided or with just with my rollator.  I could not independently perform activities of daily living.  I had my Actemra infusion 2 weeks after the 2nd vaccine shot and had to be taken in by wheelchair.  This continued with slow progress to doing better with Actemra IVs, Solumedrol by IV, and taking all RA meds.  My labs 5/25/21, 5 weeks later, showed my Sed Rate was 80, my CRP was 68.1, and the RF Titer was 1280 - and this was significant improvement.  As of 10/7/21 my Sed Rate was 23 and the CRP 4.
Patient called to report that since getting home after her COVID shot, she felt dizzy and was itchy on her arms and legs. She had eaten food and drank water, but was still having issues 2 hours later.
Patient has had pain in left arm since the vaccination on 7/9/18. She reports that she cannot use her left arm and it hurts to move the upper arm. She can use her wrist as long as she keep the upper arm still. She has not had fever or any other symptoms. She has redness over the left deltoid and has tenderness with touch. She has restricted range of motion of the left shoulder.  Distally, her sensation and strength are preserved. Her bicep DTR is 2+ bilaterally.
pt recvd vax 17NOV95 lt arm swelling size of orange began 19NOV95; pt contacted 20NOV95 advised to put ice packs on it & take APAP;no further complications as of 21NOV95 swelling subsiding;
no additional AE reported; product administered to patient after temperature excursions; This spontaneous report was received from a medical assistant referring to a 12 month old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 27-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # U008180, expiration date on 12-MAR-2023, once, for prophylaxis (dose, and route were not reported). The vaccine was administered to the patient after temperature excursions as follows:7.4 F degrees for 0 hours 25 minutes 0 seconds, 6.4 F degrees for 0 hours 20 minutes 0 seconds and 5.9 F degrees for 0 hours 15 minutes 0 seconds. There were previous temperature excursions at 31.3 F degrees for 10 hours 28 minutes 0 seconds; between range 6 F degrees to 14 F degrees; no exact temperature was provided; for 1 hour 15 minutes 0 seconds; 11 F degrees for 4 hours 6 minutes 0 seconds.No additional adverse events were reported. No product quality complaint involved.  This is the report number five out of seven total.
Patient called after approximately 1 and 1/2 months after receiving vaccine stating she's having issues with full-body hives that are forming blisters and leaving scarring/discoloration of her skin. She's also having issues with nerve pain along with sensation loss/loss of feeling in her extremities.
I exp pain, stiffness of my hips, low grade fever, inflammation of shoulders, elbows and hands. I was immobilized for 8 weeks total. Due to my adverse events I couldn't get myself dressed or shower. I now take steroids twice a day the condition was diagnosed as polymyalgia rheumatica.
It was reported that a pt (4 of 4) complained of redness and rash 3-4 inches in diameter after receiving the 98-99 Fluzone.
Pt denied any adverse reactions and stated that she felt fine. Pt stayed in room with me after it was noticed that vaccine was given 1 month too early and there was no signs/symptoms of adverse reaction to the 4th Moderna booster.
A non-serious spontaneous report of H1N1 LAIV sprayed into eye and eye turned blue has been received from a physician concerning a child patient, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 8-Dec-2009 for an unknown indication. On 8-Dec-2009, while receiving the H1N1 vaccine inadvertently sprayed into eye. Parent reported to physician that the eye turned blue. The outcome of medication error was recovered and the outcome of the eye turned blue was unknown.
Chronic eczema condition worsened significantly, particularly around scalp and trunk, with some hair loss due to eczema.  Worsening began in December, and has occurred  until current date. Beginning prednisone treatment
flublok being administered to pediatric patients with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA418226(CLUSTER), 2022SA419186(CLUSTER), 2022SA420094(CLUSTER), 2022SA420021(CLUSTER) and 2022SA420025(CLUSTER).  This case involves a 5 years old female patient who was being administered influenza quadrivalent recombinant vaccine [flublok] to pediatric patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the pediatric patient received a 0.5 ml (once) dose of suspect influenza quadrivalent recombinant vaccine (lot QFAA223, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for influenza with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flublok being administered to pediatric patients with no reported adverse event).  Outcome Unknown  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 the 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.
15 year old received Pfizer COVID-19 vaccine, Pfizer EUA states patient should be >/= 16 year old.
Information has been received from a 25 year old female with no drug reactions/allergies and no pertinent medical history, for HPV, a Pregnancy Registry product, concerning herself who on 28-NOV-2011 was vaccinated with her first dose of HPV vaccine (lot# not reported). There was no concomitant medication. The patient reported she received her first dose of HPV vaccine on 28-NOV-2011, found out she was pregnant in December 2011, and estimates she conceived between November 16th through the19th. No adverse effect reported. The patient sought unspecified medical attention. No lab diagnostic study was performed. Therapy with HPV vaccine was discontinued. The patient's LMP was approximately 16-NOV-2011 (also reported as "10 weeks"). The estimated delivery date was 22-AUG-2012. Follow up information has been received from the physician via a nurse who stated that the patient had a normal delivery and a healthy baby in August 2012. Additional information is not expected.
8 days after the shot my shoulder started feeling sore to the touch. I started feeling a little under the weather. With weak joints and run down. On Sunday a circular red mark about the size of a baseball appeared. Every day the mark became larger and then started to become raised. And redder. That lasted 6 days through 3/18/21. Today it is starting to fade. The red blotch was slightly itchy but not unbearable.
Approxiately 5 minutes after vaccination, pt reported feeling light headed and started "slumping" in the chair. Pt assisted to supine position, feet elevated. Pt stated that he could not move or feel his hands and arms, then subsequently began to arch his back in possible seizure activity. Pt's hand were contracted and generalized tremors noted. Pt diaphoretic and seizure activity intensified. Approximately 10 minutes after vaccines given EMSA called. Oxygen applied and emergency services established IV access. Generalized tremors continued, pt appeared dazed.Released to EMSA for transport to Hospital. Pt improved while being placed into ambulance and was released. It has now been 45 minutes after vaccination. Pt still shaky and dizzy and remained supine in the clinic until tranportation arrived to take him home. Was seen in the emergency department later in the day for follow-up and their determination was that pt had had a vasovagal resonse to the vaccines.When contacted the next day, pt reported that he still felt slightly dizzy, but otherwise improved.
Infant developed diarrhea day following vaccination becoming more severe 48 hours.  Stools green and of foul odor.
body aches, flulike symptoms, numbness to right arm and lump to right armpit. Narrative:
1/11/2018- bruising at the Dtap injection area. Redness around the IPV and Chickenpox injection sites RN advise cool pack on and off throughout day, TYLENOL or MOTRIN for discomfort. 1/12/2018- bruising at all three sites and redness. Hard and warm in AM. Treatment- Ice and MOTRIN. In the afternoon of 1/12/2018- site was soft and bruising fading.
generalized weakness Narrative:  Per supervisor report, employee called off work today c/o generalized weakness  Other Relevant History:
This spontaneous report was received from Licensed Practical Nurse referring to a male patient of unknown age. No medical history or concurrent conditions were reported. On 21-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 dose 1 (strength, route and lot number were not provided). Concomitant medication was not reported. On 27-JAN-2016, the patient was vaccinated accidentally with a second dose of PNEUMOVAX 23 (strength, route and lot number were not provided). No adverse effect was reported. It was also reported that no product quality complain was involved. The patient's outcome was unknown. Additional information has been requested.
Chills, soreness in center of chest, headaches, and lack of energy.  Symptoms stopped after two days.  Light headache on 11/1/21 but seems to be going away.
purple bruised spots appeared on head spreading to forehead w/in 10min of vax;splotches were still there though faded somewhat 30hr later;
Medical Assistant reported a pt with history of chronic pain and possible fibromyalgia received a vaccine on 6/7/2000. The next day pt developed severe arm pain, arm numbness and weakness. In the following day the pt experienced pain almost everywhere had difficulty sleeping and eating and lost 9 pounds.
Headache  for 3 days; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache  for 3 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ORAL CONTRACEPTIVE NOS and LISINOPRIL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache  for 3 days). At the time of the report, HEADACHE (Headache  for 3 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No corrective treatment was provided.
Extreme pain in entire left arm; extreme itching of left arm; limited movement of left arm; inability to raise left arm; inability to perform routine hygiene and duties; pain made driving extremely difficult. This lasted for at least 7 months. Subsequent treatment included physical therapy, an ultrasound, an x-ray over a period of 9 months.
Swelling of left arm from shoulder to elbow.  First noted to be swollen 09/09/08 by maternal grandmother at about 1515.  Mother reports arm swollen, red, and hot.  Arm iced and Tylenol given.  Mother reports child woke up crying a couple of times during night.  Mother reports arm is not as red today and skin on arm is not as tight, however arm remains swollen.  Left arm at axillary and around deltoid measures 9 1/2 inches and just above, elbow is 7 1/2 inches in circumference, compared to right arm circumference measurements of 8 inches at deltoid and 6 1/2 inches above elbow.  Referred to medical provider at family practice center for further evaluation.  Child has been afebrile since onset.
pt recv vax; erythema, edema, tenderness at inject site; cellulitis at inject site;
Th, e patient is on her 3 weeks post partum. She felt dizzy, anxiety. She takes lLmictal for seizers. Pulse 64  respiration 10 spo2 98% bp 90/55 at 12:10 pm She felt better and her husband took her to door on wheelchair to discharge on 12:36pm
p/vax pt noticed a rash around neck-under a silver necklace-exp an inc in rash w/burning of skin;rash has weepy, scalded appearance;itchy;allergic type rxn;maculopapular rash that looks consistent w/allergy;
headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
02/01/2021 At work, all of the sudden I could not read papers, it's like I lost part of my vision, husband searched net and called my daughter who is a nurse and she said to take her to ER if not gone in 20 minutes. So since I was still experiencing it, I went to ER with husband driving, about half hour away it got better but we went to ER anyway. . About the same time I developed mouth sores, dentist diagnosed it, Lichen Planus, Still experiencing this symptom.  2 to 3 weeks ago I had an episode where all of the sudden my shoulder was sore and it hurt to breathe, pain continued through sleep, similar to pleurisy.
Pfizer-BioNTech COVID-19 Vaccine EUA  - fatigue, fever, headache, injection site pain