chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's child. The age at vaccination was not reported. The patient had received shingles vaccine and experienced pain. The follow-up would not possible as no contact details were available.  This case had been linked with US2021AMR066108 and US2021AMR066117, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066108:Reporter's case US-GLAXOSMITHKLINE-US2021AMR066117:Sister's case
I have a large, swollen, painful area under my left arm, in the armpit, that has been diagnosed as cellulitis. I am on a 10 day course of antibiotics. My left arm, where the dose was given, is red, slightly swollen, and sore to the touch. My doctor has advised to continue to take ibuprofen and to treat with ice packs. I would expect it to resolve in ten days when the antibiotics are completed.
This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 58-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 3rd October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced pruritus, feels awful and erythema. On an unknown date, the outcome of the pruritus, feels awful and erythema were unknown. It was unknown if the reporter considered the pruritus, feels awful and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. After receiving SHINGRIX, the patient experienced redness, feels terrible and itching. The patient actually felt so bad that she went to walk in clinic day before reporting to see someone. The reporter had not answer if this was first time reporting or follow-up.
Pain in arm, unable to lift arm in front of body or to cross body, also can not lift arm to shoulder height.  Has been using ibuprofen, especially at bedtime to help with sleeping.  Patient does not report any swelling, hot-to-touch feeling or fever.  Patient contacted us for advice.  I recommended Tylenol and ice and to call the doctor.  Doctor's office advised her that this could last up to 6 weeks and also told her to use ice or heat and Tylenol or ibuprofen.  They thought probably tissue damage.
After 10 minutes of my 3rd dose I started having allergic reaction. I experienced lightheaded, pressure in my chest, and difficulty breathing. I even broke out with rash on my right arm. Since I was at the clinic when it all started the people there called ER. When I was at the ER the doctor's prescribed me with a medication more stronger than BENADRYL. I don't know the exact name of it. They also gave me IV with saline fluids to clear my body. They advised me to drink plenty of fluids. It took me 3-4 days to fully recover.
Loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of appetite lost in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 18 January 2019, refer case US2019163762), Afluria quadrivalent with an associated reaction of fatigue (received the year before the date of reporting and experienced nausea, vomiting,  itching, fatigue, flu like symptoms and achiness) and Benadryl (pre-medicate with 50mg). Concurrent medical conditions included chronic spontaneous urticaria.   On 3rd May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced appetite lost. On an unknown date, the outcome of the appetite lost was unknown.   It was unknown if the reporter considered the appetite lost to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the issues were milder, she had no nausea, but did have loss of appetite and again lasted for about 2 days.      She states she has been told by her physician that due to the idiopathic urticaria that she has, her mast cells de-granulate when she gets a vaccination and that was what causes a more pronounced reaction that she gets. The reporter consented to follow up. This case linked with US2019163706, US2019AMR165479, US2019163762, US2019AMR165480, reported by same reporter.
Guillain-Barre Syndrome - symptoms started within 2 weeks after being given the vaccine Menactra.  At first, my daughter complained about trouble going up a flight of stairs.  Within 2 weeks of difficulty going up the stairs (she participates in the sport CREW so her legs and body are in excellent condition so these complaints were odd) she then started saying that her legs were hurting a great deal and she had pins and needles in her feet.  The next day she had trouble standing and taking steps - she started to fall down after taking 2 steps.  This was August 24th and she was seen by a private doctor.  On this day at the doctor's office she also had a debilitating headache and vomiting and patient had decreased reflexes in both her legs.  Blood tests were ordered.  Following day I took her to the Emergency Room and was told even though she had no reflexes in her legs she would be released and told to rest. Blood work and a CAT had been performed but nothing showed up in either test.  On August 26th I took her back to the ER early in the day because the pain in her legs was more intense and by now patient could no longer stand up on her own.  She was still vomiting and had the headache.  She was admitted to hospital after she was given a lumbar puncture which showed a high protein count.  My daughter was placed in ICU and was put on a ventilator after she started having trouble breathing.  At that point, she had lost her ability to swallow, talk, breath and move limbs.  She was fed through a feeding tube.  After spending three weeks in the hospital, she was released on September 14, 2005 and immediately taken by ambulance to rehab where she will remain for at least 60 days so that she can learn how to swallow, talk and basically learn all over again how to take care of herself including how to sit up and use her arms and legs.  She will probably need to do out-patient therapy several times a week after she is released from the rehab. Information from 60 day follow-up report states: Pt continues to go to physical and occupational therapy as an outpatient. Pt is unable to walk for more than a few minutes without having to rest. She wears a brace on her right leg to correct a drop foot. Pt still needs to use her wheelchair. Pt at this point, as an 18 yr old girl, is unable to go to school or work as per her doctor's orders. She has had to put off her plans for herself for the time being. 12/31/09 Right ankle-drop foot- I wear a brace to support the ankle. Both legs-I have diminished flexibility in both legs and I suffer from cramps and spasms in my legs.
received her first dose on 03/12/2021 at 10:30 AM.  Later that day,  she only mentioned slight soreness at injection site. In the early morning hours on 03/13/2021 she became anxious and having very irrational and disjointed thinking. She got into the pool (unheated) by herself, unbeknownst to any other family members in her athletic clothes she was in and was then found across the street at a neighbors house (she did not know them), standing  on their doorstep in wet clothes at 5:45 AM on 03/13/2021. Her confusion, irrational thought, anxiety and paranoia has increased to the point of having audio/visual hallucinations and sleep disturbances. Prior to the vaccination, she did not exhibit any of these behaviors or symptoms.
1st dose at 6 years old; patient received 1st dose at 6 years old and 2nd dose at 11 years old.; no additional AEs; This spontaneous report was received from a nurse and referred to a 6-year-old female patient. The patient's concurrent conditions, concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.  On an unknown date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter (ml), lot #, expiration date, anatomical location and route were not provided) at 6 years old for prophylaxis (product administered to patient of inappropriate age). On an unknown date, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter (ml), lot #, expiration date, anatomical location and route were not provided) at 11 years old for prophylaxis (inappropriate schedule of product administration). The patient was new to practice and information was provided in patient's vaccination records. No additional adverse event (AE) (no adverse event).
Enlarged painful lymph clavicular lymph node, neck swelling, mild ear pain- same side as flu shot.
Arexvy Vaccine not reconstituted but administered; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Arexvy Vaccine not reconstituted but administered) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-OCT-2023 Arexvy vaccine not reconstituted but administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Information has been received from a physician concerning a 23 year old female with yeast allergy who was vaccinated with a dose of RECOMBIVAX HB.  It was reported that the patient had sweaty palms and redness at the site of injection.  The physician stated that it was a different physician that administered the vaccine.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
After the administration of the vaccine, while waiting for the observation time, I lost consciousness for more than two minutes, I completely fainted and all my muscles contracted until they were rigid. From the symptoms the doctor said it was a tonic-clonic seizure, and that it was a side effect of the vaccine. They told me I turned purple, stopped breathing, and exhaled the remaining air until I stopped breathing for about 30 seconds until then I came back to my senses. The firefighters examined me and all my vital signs were fine so they recommended that I go home and rest.
One dose of benadryl was given for the itching. Patient did not wanted to wait 15 more minutes and insisted on leaving saying the benadryl was going to help the itching go away.
1st dose was given on 09/11/21. Gave vaccine on 09/25/21. During billing realized that vaccine was given 7 days early.
10 hrs after FLUZONE booster, pt developed gasping, blue eyelids and pallor. All resolved w/o Rx.
went to get a booster dose but was given a 3rd dose (0.5ml) for the immunocompromised instead; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (went to get a booster dose but was given a 3rd dose (0.5ml) for the immunocompromised instead) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Cyst removal (In July she had a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed.). Concurrent medical conditions included Systemic lupus erythematosis.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 28-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (went to get a booster dose but was given a 3rd dose (0.5ml) for the immunocompromised instead). On 28-Oct-2021, ACCIDENTAL OVERDOSE (went to get a booster dose but was given a 3rd dose (0.5ml) for the immunocompromised instead) had resolved.            No concomitant medications were reported.  No treatment medications were reported.    In Jul 2021 she had a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed. It was a lymph node. She states that it was huge & that it was about the size of a bird's egg. She states that she had other lymph nodes in her arm near her elbow that were enlarged but not removed. They did not find anything wrong with the removed lymph node.   This case was linked to MOD-2021-368093 (Patient Link).
pt did not respond to Engerix-B vax series; 15JAN92 HBSAB neg; 1 booster dose given;
Six year old boy received Fluzone HD instead of Fluzone Quadrivalent. No adverse effects have been; Six year old boy received Fluzone HD instead of Fluzone Quadrivalent. No adverse effects have been; Six year old boy received Fluzone HD instead of Fluzone Quadrivalent. No adverse effects have been; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 6 years old male patient who was vaccinated with 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot #UJ280AA, exp; 24 May 2020) via intramuscular route in the left arm  instead of INFLUENZA VACCINE INACT SPLIT VIRION 3V on 24 Oct 2019.  Patients medical history included sick.   It was a case of actual medication error due to Wrong vaccine administered, Inappropriate age at vaccine administration and overdose.   At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
After leaving the pharmacy area she became dizzy and passed out. Patient recovered after resting a while and left with her family.
10cm X 7cm indurated erythematous area on right lateral thigh. No fever, nontender to touch, able to move extremities.
SIDE EFFECTS; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: post-menopause. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 171808, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20220242180.
Fatigue, arm soreness Narrative: Fatigue, arm soreness; took tylenol.
I could actually feel the vaccine entering my blood stream above and below injection area.  I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness.  Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.
06/28/2022 I woke up with a scratchy throat,  and tiredness. I tested positive on 06/29/2022 . I did a tele health with my doctor that day. She prescribed me Paxlovid for 5 days. This was a mild case. After couple of days I started feeling better. I had a metallic taste from the medication.  On 07/08/2022 I got a scratchy throat again. I had a rebound case. I just got better by my own.
This case meets criteria for vaccine breakthrough review.  Tested positive at outside facility. SxS include cough, SOB, altered mental status.
severe vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "severe vertigo". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On the day following the vaccine, she developed itchiness of both ears which spread to her entire face.  She also has facial edema, erythema with a few erythematous papules scattered over her cheeks.
8/20/2022:Patient complained of pain to site right after vaccination, no notable breathing difficulty noted. Patient was monitored for 20minuts and sent home. 8/24/2022: Patient returned to clinic with complaints of pain and redness to the site and an induration of 15mm. Pt assessed by a provider and sent home. No Medications given at this time.
Caller received 1st dose but not 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose but not 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose but not 2nd dose). On 18-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose but not 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.  This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information was received on 18-May-2021, No new information was provided.; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
9 years old received Flublok during a Flu fair/no ae; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked with 2019SA307219  This case involves a 9 years old patient who recieved INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] during a flu fair.  On 22-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1930, expiration date: 30-Jun-2020 via intramuscular route in the left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred.  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 and Module VI of the 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.
local reaction to varicella vaccine. Tender, red, hot swelling of entire upper (R) arm within 24 hours of vaccine administration
I was very fatigue, nausea, the day I went to the doctor I was very tired, I couldn't walk, they did a COVID-19 test on 12/20/2022 and it was positive. They prescribed PAXLOVID, when I took it, my mouth tested like metal, I called the doctor and he said stop taking, I felt a little bit better after that, I stayed away from everybody. Now I have problems with my teeth, I never had problems before and now they are very sensitive. I have an appointment with the dentist on the Feb 10, 2023. and then my doctor on Feb 13, 2023. I had another home test COVID-19 test on 12/30/2022 and it was negative.
I have hx of episodes of sudden elevation of BP and pulse with accompanying other symptoms from possible adrenaline surges. When I sat down for my observation period, it felt like the start of one of those episodes except I had tingling in my hands which was different and a metallic taste in my mouth. Pulse and respirations were normal. Took many slow deep breaths to help calm the possible adrenaline surge I thought I was starting to experience. Felt ok by the time I was released from the 15 minute observation area. After driving about 5 minutes towards home, I started to get chest tightness and my throat felt strange and swallowing was not normal. I didn't feel well in general. No rash or hives. Breathing was ok. When I got home, I took 2 Benadryl. After two hours I felt much better except for the chest pain which felt like my "normal" atypical chest pain and lasted a little while longer. The chest tightness was gone though and the throat and swallowing had improved also.
Conjunctivitis wit herythema and pus (patient had similar reaction to previous Hep.B vaccine). On 05/04/2017 patient developed shortness of breath. On 05/05/17 developed tonic-clonic seizures.
Information has been received from a physician concerning a 2 month old female who on 12 Oct 2006 was vaccinated PO with the first dose of Rotateq (human bovine). The physician reported that on 12 Oct 2006, immediately after being vaccinated, the patient vomited. The physician felt that the entire dose was lost. Unspecified medical attention was sought. On that same day, the patient was considered to be recovered as she did not exhibit any further symptoms. Additional information has been requested.
Patient reported he woke up on 9/7/21 with a numb left arm, that felt like pins and needles, and could not make a fist with his left hand. He said there was a loss of blood flow to the arm, and it felt painful from below the injection site for his covid vaccine to his fingertips.  The patient also reported that within a few days of receiving the 2nd dose of his Pfizer vaccine on 8/27/21, he developed hives  that spread all over his body, some were quarter size welts. He went to the hospital for this on 9/4/21 and was treated with clindamycin per patient report.
First dosage: sore arm  Second dosage:  Headaches, chills, nauseated, lump under left arm pit, and sore arm