chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild bell's palsy of the left face that started 4 days after the vaccine was given
hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
Arm pain, infected bump (L) arm. (L) deltoid with 2 cm induration/erythema with small crusted pinpoint vesicles. (+) firm with pain at shoulder. NV intact likely rxn. Pain: 7/10. Pain to move, tingly (L) arm. MOTRIN.
After about 1 hour and 15 minutes, I began to feel my throat swelling, difficulty to swallow, nausea, hot flashes, my heart racing, a rash on my chest, and my tongue tingly.
On 10/07/2019 at 2:50 pm RN, administered IM to Right deltoid, Hep A vaccine , Havrix. Within a minute of vaccine administration patient stated that she was feeling light headed. Offered cold water which she drank. After a couple of minutes she became lethargic and passed out. Ammonia capsule was used under her nose. After a few seconds she became responsive again. Patient continues to c/o feeling nauseated. B/P 90/60 with manual cuff.  Patient lowered to the floor and feet were elevated. Stated that helped some. Patient remained in this position for several minutes. Once patient able to sit upright she drank some cola. She stated she still felt weak. Her b/p 128/76.  Was advised she would need someone to drive her home for her safety. Patient called her grandmother who arrived and patient released to her. Patient was able to ambulate to lobby unassisted without difficulty.
Within two minutes after administration, patient became weak, wasn't able to hold his head up very well, and was vomiting. The vomiting was not profuse, only a very small amount. He started to feel better quickly. EMS was called, arrived within five minutes, checked on him, and they all decided he could go home.
Lymph node under right arm pit swelled up to 2-3 times its normal size and lasted for 6 days.
PT GIVEN VARICELLA VACCINE ON 12/31/08 PRESENTED TO OFFICE ON 01/20/09 WITH PAPULAR RACH EXTENDED FROM HEAD TO EXTREMITIES.  INITIAL POX ARE SCABBED OVER AND DRYING ADDITIONA POX BREAKING OUT
Complaints: Lightheaded elevated BP 167/98 (she  did not take her BP med this yesterday and this morning) HR 62 Sp02: 99%
2 months after taking the vaccine he started having red spots starting on his feet and legs and moved up to his torso.  His skin became thick and leathery, dry and peeling. It goes through cycles. He went to the ER and has seen a dermatologist.
Received flu shot 110/28 at 12:40 PM left arm; went home. Left to go to grocery store; returned home. Said I feel lifeless; right arm and leg felt weak. 10/29 woke up with flushed face, BP 170 (takes 2 antihypertensives each day). Wife called doctor; went to ER. CAT scan negative for CVA, agitate, loud; was admitted and sedated. Neurologist said it had to be the flu shot. Discharged 10/30; still drags right leg and right arm. Feels numb but can tell improving every day. Medical records received on 2/02/2005 states headache and adverse drug reaction. Follow up 01/26/05: He is still unusually "jumpy" and our doctor has prescribed muscle relaxers to help him still at night so that he can sleep. And I have had more colds this year, after the shot, than I 've have had. We hope that when spring gets her, the vaccine will have gone from his body.  Never, no more flu shots for us.  Per annual follow up" Temporary paralized on left side and talking and acting crazy in hospital night and day. He is ok now. But it has taught us a lesson which is never take another flu shot.
- Bloody diarrhea - Diarrhea - Loss of consciousness - Headache - Lethargy - Fever - Chills
Breakthrough case after 4 vaccines Pfizer 2/16/21 Lot# EN6200;  Pfizer 3/9/21 Lot# EN6207;  10/12/2021 Pfizer Lot# FC3181;  Pfizer 10/11/22 Lot# GJ6665
raised area of skin around the injection site; soreness around the injection site; first dose - 11/5/19 - not received the second dose yet; redness around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved and the outcome of the incomplete course of vaccination was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and reported a raised area of skin around the injection site, redness around the injection site, and soreness around the injection site.  The patient reported the soreness around the site and raised area around the site lasted about a week and then resolved.  The redness around the injection site lasted about 10 days and then resolved. The patient had not received the second dose yet, which led to incomplete course of vaccination. The reporter did not consent to follow up. The reporter did not had lot number or expiration date information to provide. The reporter did not give permission to follow up with HCP.
Woke up early a.m. after Flu shot given-with hands itching- palms, in between all fingers, front of hands as if I had hives.  Checked hands and they were not red, not nay hives.  Itching continued until around 6:00 a.m. at times almost intolerable.  Ran hands under cold water for 30 minutes or so trying to stop the itching.
This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9, lot# : N004798, expiration date: 31-OCT-2019 for prophylaxis (route of administration was not reported). The administered dose of the vaccine experienced a temperature excursion 32 Fahrenheit  (°F) to 35° Fahrenheit  (°F) for 6 hours, as recorded by a data logger. There were no adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010758.
A 5 year old patient experienced itching at injection site after post exposure treatment with RabAvert. The patient received RabAvert 1 ml intramuscularly on 08/17/04. His past medical history and concomitant medications were unspecified. The patient was bitten by a rabies infected cat and received treatment with RabAvert. On 08/18/04, one day after vaccination, he complained of itching at the injection site. No other signs or symptoms were noted except for redness at the site, which may be due to his rubbing the affected area. The adverse event resolved on 08/20/04 and he received his next scheduled RabAvert treatment.
Broke out in hives the next day.  On the 2nd day she had a 102 degree fever and sore throat with a cough.  Hives lasted 9 days.  Fever broke after 5 days.  Gave Benadry, Tylenol, Motrin.
Narrative: Pt tested positive for COVID 1/6/22 despite being fully vaccinated; pt with mild rhinitis and headache that resolved on its own; pt declined referral for monoclonal antibodies for treatment given he is asymptomatic.
This spontaneous report was received from a Licensed Practical Nurse refers to an approximately 2 year old female patient. On an unknown date in 2005, the patient was vaccinated with dose 1 of VARIVAX (Merck) (lot#, expiry not reported). On an unknown date in 2006, the patient developed shingles. Patient sought medical attention(saw the doctor). The patient received the second dose of VARIVAX (Merck) (lot#, expiry not reported) in July 2009. The outcome of shingles was reported as recovered. Additional information has been requested.
Brain fog,  feeling of tightness in throat that comes and goes. Slight dizzyness
soreness at injection site for a week, fatigue for 1-2 weeks Narrative:
I experienced a blood clot in my calf 22 days following the J&J shot.  I have never had anything like this before.  I am a 57 year old healthy male who exercises 3-4x/week.
Arm soreness. Extreme flu-like symptoms for about 48 hours; fatigue, brain fog over the next couple of weeks to couple of months. Fatigue and weakness of my muscles continued too. Irregular heartbeat, I have always had it, but it has gotten significantly increased. This week I haven't been able to work this week, heart palpitations and irregularities. I began to have trouble swallowing, that continues to this day. They are treating me for acid reflux which I haven't had in my whole life OTC generic Prilosec. It does seem to be having some with those symptoms that are like acid reflux. I have had a bunch of ENT visits. Severe weakness and extreme fatigue and brain fog lasting for weeks, and then ongoing Cardiology issues, worse than ever had in my life.  Neurological issues, weakness and numbness primarily on right side of body is worse but it can be bilateral too. So far, no significant finding. Cardiology treatment, high doses of sodium and steroid to try to retain metabolic substances, but they aren't sure if that is the right avenue. Missing work, it's getting worse. Since my vaccination, 5-6 days of work and this past week has been significantly worse due to my symptoms. A lot of testing has been done.
2 nose bleeds within week of first shot. Normal period started 3/25 in morning and stopped completely by afternoon.
Syncope and collapse 1 minute after administration with seizure-like activity lasting 30 seconds. Post-ictal state for 30 minutes.
Approximately 10 minutes after receiving vaccination I was called to the observation area where patient was complaining of difficulty swallowing and tightness in the chest.  She denied itching, wheezing or difficulty breathing,  lightheadedness, nausea,  swelling of lips or face or mouth. Also denied  history of anxiety.  Patient was mildly anxious, not in distress, verbalizing  well. No visible urticaria or oral abnormalities, no angioedema.  lungs clear heart RR&R.  She c/o worsening sense of difficulty swallowing and tightness in chest and was given an EpiPen dose of .3ml IM.  She improved thereafter regarding subjective symptoms but became "jittery."  paramedics arrived and evaluated her, asked her to stand up (from reclining) and she did well.  Approximately 30-40 minutes later she was picked up by family members and asked to follow up with ER, paramedics or PMD as needed. i advised that I did not see a reason to not get the 2nd dose of vaccine .  I gave her my name and contact information.
07/12/03 Tenderness, swelling, tightening and discoloration in upper part of arm that received inoculation.  Whole arm aches when used; numbness and tingling in whole arm including hand.  Difficulty in performing essential work-related tasks. Patient is ~5 months pregnant.
Woke up the next day (3/11/21) with body aches, joint pain, headache, nausea, low grade fever (100.3), swollen glands in throat, right arm soreness that extended into tricep muscle and into axilla on right. The second day (3/12/21) after injection woke up with significant muscle soreness in right tricep and swelling in right axilla.
gum sensitivity upper teeth front; night sweats; prolonged heavy flow period; prolonged heavy flow period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 12:15 (Lot number: ff2589) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: latex" (unspecified if ongoing), notes: Allergy. The patient took concomitant medications. The following information was reported: GINGIVAL PAIN (non-serious) with onset 06Oct2021, outcome "recovering", described as "gum sensitivity upper teeth front"; NIGHT SWEATS (non-serious) with onset 06Oct2021, outcome "recovering", described as "night sweats"; HEAVY MENSTRUAL BLEEDING (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 06Oct2021, outcome "recovering" and all described as "prolonged heavy flow period". The events "gum sensitivity upper teeth front", "night sweats", "prolonged heavy flow period" and "prolonged heavy flow period" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of gingival pain, night sweats, heavy menstrual bleeding, heavy menstrual bleeding.  Additional information: facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. other medications in two weeks: multivitamin. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information was expected.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a 27-month-old female.  This case is submitted in accordance with an article on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 11-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the vaccines clinic on 22-Feb-2008 and the vaccine expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  The patient had no adverse events at the time the report was received, neither as of 18-April-2008 when the office was contacted for follow-up information. The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Follow-up information received 18-Apr-2008 and incorporated into he narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
This patient was immunized on 2/19/01. That evening the patient developed a fever of 101 rectally, which continued until the day of admission. On 02/21/01, the patient developed strabismus of the left eye. The patient admitted to the hospital on 02/23/2001 with a diagnosis of viral meningitis. On 02/25/01, the patient developed right eye strabismus with developing improvement of the left eye. The patient was discharged clinically stable. A physician reported via a company representative that an 8 month old male received his second injection of prevnar on an unspecified date. Subsquently, the child was hospitalized for aseptic meningitis. Follow up information received on 03/16/2001, from the child's physician revealed that on 02/19/2001, the child received vaccination with Hib-Titer and Tripedia vaccines along with his third dose of prevnar, not his second dose as previously reported. The child has since recovered. From follow-up information received on 05/01/2001, it was reported that for the request for the discharge summary with complete diagnosis and the results of cerebrospinal fluid examination need records from hospital. Additional patient, vaccine and the adverse event onset information were provided. From follow-up telephone conversation, it was stated that the reporting facility did not receive any records from the hospital because they did not admit the patient. The patient and family have since moved without forwarding information.
This literature marketed report has been received from the authors of a published literature article, and refers to a 15-month-old patient of unknown gender. The patient's concurrent condition included DNA Ligase IV syndrome, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 12 months, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver and intestine but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) only in skin and liver. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 380 cells/uL, CD4 count 73 cells/uL, CD19 count 21 cells/uL and natural killer (NK) cell count 432 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with topical steroids and intravenous immunoglobulin (IVIG) without improvement. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Nitazoxanide was given for weeks with no improvement in skin lesions. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions, but on an unknown date the patient died. The patient's death was related to HSCT. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent the HSCT procedure. This is one of seven reports derived from the same literature article (linked mars cases 1902USA004783, 1902USA004784, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788).  Sender's Comments: US-009507513-1902USA004783: US-009507513-1902USA004784: US-009507513-1902USA004785: US-009507513-1902USA004786: US-009507513-1902USA004787: US-009507513-1902USA004788:
Slight Arm pain; Slight Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight Arm pain) and PYREXIA (Slight Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B20A and 037K2QA) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Slight Arm pain) and PYREXIA (Slight Fever). At the time of the report, PAIN IN EXTREMITY (Slight Arm pain) and PYREXIA (Slight Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Slight spasms to both lower extremity muscles with severe tightness and soreness of the muscles of both lower extremities. The symptoms gradually decreased over a 36-48 hour time span with complete resolution of the symptoms at this time.
Exactly one week after the vaccine my period started, which is strange considering I?m breastfeeding my newborn (without formula supplementation). With my last child, I didn?t have a period until I stopped breastfeeding a year later. Also, my typical period lasts 3-4 days, however this one has now lasted 10 days and still has not stopped, although it is not as heavy as it was in the beginning.
Patient's mother reports patient was covered head to toe in hives approximately 36 hours after receiving the vaccine, states resolved with Benadryl use. Denies coming in contact with any new foods, detergents, or environmental items
The patients were given expired Ipol on 06may2020, no AE; Initial information received on 11-May-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA124091 (same reporter).  This case involves a 4 years old male patient who was vaccinated with 0.5 ml fifth dose of IPV (VERO) [IPOL] (lot: P1A461M and expiry date: 03-May-2020) via an intramuscular route in the right arm for prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient did not experience any adverse event. No specific symptoms were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pain @ lt deltoid, hives gen, h/a; c/o stomachache, malaise; duration of 2 days;
Rash, Acycliver 200 1/2 tp to qil 45D.