chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Raised, red rash on bilateral arms, chest and top of feet. Rash is hot and itchy. DX as photo sensitive rash. Seen on 10/01/06 and 10/2/06. Prescribed Atarax 25 mg, 1-2 tabs PO 4 times per day prn, Hydrocortisone cream 1% BID, Methylprednisolone 4 mg as prescribed, descending doses x 6 days.
Patient was only given the Dtap/IPV portion of the Pentacel vaccine/ No AE; Initial information was received on 08-May-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional (office staff).  This case is linked to case 2020SA121926 (duplicate case) and 2020SA121436 (same reporter).  This case involves a three months old male patient who received only the Dtap/IPV portion of 0.5 ml dose one of the suspect vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number U6615AA and expiry date 02-Mar-2021 via intramuscular route in the right thigh for prophylactic vaccination (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to Inappropriate reconstitution technique.  At a time of reporting no adverse event 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.
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: After receiving their second dose patient immediately started to experience what she said was tingling sensation of her arm and stated that it has got worse over time. Currently patient is stating that they are suffering from what feels like "nerve damaging issue".  The current symptoms are the following that  have been reported: Tingling sensation down both arm and legs, legs/arms feel like they are falling asleep and she is dragging them along, tightening sensation around her fingers
Patient received 1st and 2nd dose on same day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st and 2nd dose on same day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st and 2nd dose on same day). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st and 2nd dose on same day) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.
Pain, redness, swelling at the injection site, warmth, started slightly after injection was administered. By the next day it was about 4in in diameter. Pt was given an NSAID from the Dr's office.
This spontaneous report as received from a register nurse refers to a 2 month and several weeks old patient. Pertinent medical history and drug reactions/allergies were not reported. On 30-APR-2013, the patient was given an expired dose of oral ROTATEQ (Lot # 0923AA, expiration date 25-APR-2013) (dose, frequency and therapy route were not reported). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Redness and swelling in left thigh where Varicella vaccine was given appeared 6 days after imm. Fever from 6/3 - 6/5 (6-8 days after imm).
Swelling of L arm with erythema and induration at site of injection; pt also experienced upper respiratory infection-like sxs and influenza-type body aches x 7 days.
Screaming, for more than 7 hrs, period of non-motion, eyes non-focused; fever 102, more than 48 hrs (w/non ASA); Had 1 loose, green BM w/blood tinge;
Subject in pneumococcal vaccine trial, with severe COPD, was diagnosed with colon adenocarcinoma, metastatic. Vaccination took place on 1/31/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE Reporting Form upon request.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Follow up information was received from a Licensed Practical Nurse. The nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and date of vaccine administration) available at the reporting time. The nurse also stated she might fax information at a later time. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 16 years old Adolescent. The patient was vaccinated with GARDASIL on 30-SEP-2014. Lot was reported as J015378, expiration date 09-APR-2016 for the vaccine GARDASIL. Additional information has been requested.
2 STROKES ON BOTH SIDES OF HEAD; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had stroke and as per the reporter "I took the one shot Johnson & Johnson and had 2 strokes on both sides of my head and have been on a heart monitor since."   Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2 strokes on both sides of head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211258341 -JANSSEN COVID-19 VACCINE Ad26.COV2.S -       2 strokes on both sides of head -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt had reaction after giving HPV vac. Pt complain of having headaches, dizziness, numbness on L arm and weakness on both legs. Pt was seen by Dr. on 8/18/09.  9/3/09 PCP medical records received DOS 4/1/08 to 8/18/09. Patient does not feel good. Dizziness, weakness, numbness.
pt recv vax & pt felt like was in a daze for 24hr post vax;
Pt received MMR on 6/12/01 and on 6/18/01, in the AM, started having pain behind and inside of left ear, pain moved to left side of head and around left eye. Ice packs placed on eye. Pt awoke the next AM with chest pains and went to ER. She was placed on heart monitor. Pt states that PMD told her that he could not find anything wrong and that it may have been caused by reaction to MMR. Pt also stated that right arm was very swollen. She was treated with Tylenol 3.
She got her 2nd vaccine, the initial adverse reaction was seemed like what they show in the movies as narcolepsy.  She felt hot and flushed and they took her temp and it was 98.6, her normal temp is 96.8 for years.  She could not get out of bed, she could not keep her eyes open, she was sleeping 16 hours a day.  She had no strength, she could not walk, her husband had to help her walk.  On standing up she was shaky on her legs.  She could not step up a step on her porch to come into her house.  This lasted almost 4 weeks, and she is still trying to regain her strength.   She had a 3:00 PM APT that she missed, and had to reschedule it.  She went to the doctor almost a month ago to her Rheumatologist to address the pain and get rid of taking the Tylenol.  He did not address her sleeping, her BP yesterday was 180/100.  She had rapid weight gain, a nervous wreck, and he was concerned about her BP and he started her on a clinical ketogenic diet and stopped all sugar from her diet and was feeling about 60% better within 3 weeks and lost 19#.   She went to her PCP on Thursday 5/20/21 to see if she had any antibodies as she had a severe reaction and her husband was about to unmask to spend time with his unvaccinated grandchildren and have lunch with them, and she was not comfortable at that point in time to have secondary exposure and  so she went to get an antibody test to see if she needed to quarantine.  They tested her and they found that she has 0 antibodies and she is the first person that they have seen that has 0.  She then spoke to the rheumatologist assistant, and said that they are having antibodies tests that are coming back with a 0 due to the pain medications that people are taking.  The PCP's office was shocked that she had no antibodies especially after having the 2nd vaccine.  She took another antibody test yesterday and sent it back to hospital to see if there was a lab error, and is going to do another test soon and to send to another lab and if that is negative she is going to have to do a lot of research to see what she has to do to get immunity against the virus.     Where she lives, they mask and still are using precautions as her state has not opened up as much as other states.  She is always fully masked and maintains social distance protocol, which she has done for a year.   She feels that OTC Tylenol may have affected the efficacy of the vaccine.  The CDC informed her of that after she had been taking the Tylenol.   She is quite angry that the people that they are relying on to put out the information needed are not giving the info that is needed, such as she needed to know that OTC pain medications can cause the vaccine to not be effective.
Patient described a terrible itching in her eyes and palm of her hands, she placed her hands and feet into ice water due to the extreme itching. She woke the next morning with a rash on her torso and a hive on her buttock.  Patient took oral benadryl.  Primary provider advised patient not to receive the second injection of Shingrix.
Information has been received from a pharmacist referring to a patient of unknown gender and age. On unknown date in 2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, (lot # L002310, expiration date 08-JUL-2016, strength, route, and dose were not provided). No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information is not expected as the reporter did not wish further contact.
I got the Flu A with throbbing head pain almost constantly in the right side of my head and neck. No stuffy nose or anything like that. Just general pain and feeling terrible. I was bed ridden from Friday 25th June to Wednesday 30th June. My fever was up to 102 and was generally high throughout that time as well. I took ibuprofen and ate healthily, when I could eat though I had no appetite. I went to the DR and got a flu test on the 29th or 30th of June.
This case was reported by a healthcare professional and described the occurrence of injection site rash in a 64 year old female subject who was vaccinated with Influenza virus vaccine Trivalent (FluLaval) for prophylaxis. The subjects medical history included acquired immune deficiency syndrome. On 10/23/06 the subject received a dose of FluLaval in an unspecified arm. The healthcare professional noted that at the site of the FluLaval injection, on 10/30/06, 7 days after vaccination with FluLaval, subject experienced a breakout of rash on the arm of the injection site with a black dot in the middle of the injection site. The subject was seen on 11/17/06 at a physicians office and was treated with Benadryl. The healthcare professional considered the events were clinically significant (or requiring intervention) (OMIC). The outcome of the events was not reported.
Fever 104 Shaking chills for 2 nights. Nausea Vomiting Diarrhea Exhaustion Weakness Dizzy Unable to eat.
Pt recv vax on 11/4/98; on 11/5/98 pt exp swelling, redness & warmth at vax site
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 27-OCT-2014 (also reported as "today"), doses of PNEUMOVAX 23 that were exposed to a supported excursion were administered to unspecified patients (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse experience has been observed or reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Pt recvd vax 6OCT93 immed following felt flushed & exp dizziness, hyperventilating & felt like throat was closing; devel facial erythema; addtlly was swelling, ecchymosis & exp pain & numbness radiating into rt hand; anaphylactic react;
called on behalf of a HCP who reported her daughter received her first GARDASIL 9 injection approximately 2 years ago and developed a seroma at the injection site.; This spontaneous report has been received from a registered nurse and refers to her daughter, a female patient of approximately 11 or 12 years. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an unknown date in 2021 (reported as approximately 2 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis (dose, strength, lot number, expiration date, vaccination scheme, route of administration was not provided).   On an unknown date, the patient developed a seroma at the injection site. The operator of the device was unknown by the reporter. The patient had not received the second dose due to wanting to know what the commonality and risk of reoccurrence was with side effects/adverse reactions. It was unknown by the reporter if the patient sought medical attention, if she received any treatment or if any laboratory diagnostics or studies were performed. The patient recovered from the event.   The causal relationship between the event with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
9/8/21-Patient was COVID-19 tested for preop prior to undergoing a C Scope/EGD for difficulty swallowing.  Procedure was cancelled
This spontaneous prospective pregnancy report as received from a consumer refers to a female patient of unknown age. The reporter stated that his wife went into the office to get a flu shot (unspecified) and inadvertently was given a first dose of 0.5 ml intramuscular GARDASIL (lot#1291AA) on 19-OCT-2012. The patient was 35 weeks pregnant. The LMP was approximately on 24-FEB-2012 and EDD was not provided. She went back to the office of the health care professional (HCP) to have a sonogram performed, she was also given a urine test and a vaginal and rectal swab (results not provided). No adverse reactions were reported. Additional information has been requested.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pmh significant for cancer metastasis to liver, esophageal cancer stage IV, protein calories malnutrition, adrenal adenoma, renal cyst, fatty liver, hx of cerebrovascular accident, hypertension, t2dm, sleep apnea, hyperlipidemia, tobacco use. Pt was under the care of hospice at time of passing. Patient suffered ulcer bleed in January. Pt also suffered from nausea and vomiting before time of passing.
A report was received from a consumer on 12/23/03 concerning an 11 month old male vaccinee who inadvertently received Fluvirin on 12/8/03. On 12/8/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Currently 33 weeks pregnant. Following morning after shot I woke up with severe chills. I was experienced severe weakness and I was really tired and I could not get up all day. I did not have a fever but i felt hot. The next day I was better.
Rash, raised bumps,red, itchy. (r) axillary torso
Headache, seeing spots.  Mother requested EMS transport.  EMS assessment was unremarkable, no vital sign issues.  Follow-up with parent indicates ER MD found no relationship to the vaccine.  Classified as a nervous reaction to the injection.
Severe chills, shaking, fever, nausea, vomiting, sweating, dizziness, light headedness,  muscle pain, joint pain. Symptoms started approx. 7 hours after injection and were 90% gone approx. 24 after injection.
L arm swollen and red more than the size of a half dollar with fever. Rx Aug 500 BID.
18SEP tender reddened area around DT inject site; Keflex started; 19SEP swelling dec;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants and treatments were not reported.   Reporter did not allow further contact
Left arm swelling and itching Narrative:  Left arm with swelling and itching around border. Swelling about 3-4 inches wide and about 2 inches long. No pain.
Narrative: COVID infection following COVID vaccine series 02/17 Janssen, dose #1 (non-facility) 08/06 COVID swab, result: detected 08/06 pt cc: cough, myalgias, rhinorrhea, exposure: COVID-19+ son 08/11 clinically resolved 08/12 SAR-COV-2 LINEAGE result: B.1.617.2 08/12 SARS-COV-2 CLADE results: 21A Delta
This spontaneous prospective pregnancy report as received from a physician refers to a 31 year old female patient with obese and hypothyroid without history of drug reactions or allergies. On an unknown date, while she was pregnant, the patient was vaccinated with GARDASIL, 0.5 ml, once, intramuscular, lot #J012438 and RHOGAM. Concomitant therapies included LEVOTHYROXINE SODIUM and some prenatal vitamins (manufacturer unknown). The doctor meant to give the patient RHOGAM, but mistakenly gave her GARDASIL. Patient did not seek medical attention or receive any treatment. No laboratories were performed. The patient got her LMP on 16-JAN-2014 (reported as 29 weeks and five days") and EDD of 23-OCT-2014. At the time of report the pregnancy outcome was pending.  Additional information has been requested.
I got covid-19 arm 2 weeks after my vaccination.  It is red, hot, burning, sore and itchy where I received my maderna vaccine.  It was first noticed 3/13/21 and is bigger today, about 6 inches so far.  Any support will be greatly appreciated. Thank you.
Pt arrived at mobile vaccination site to receive COVID 19 vaccination. In screening process, pt stated that this was his first dose of COVID 19 vaccine.  Pt was registered and then the Moderna Vaccine was administered at 0925. When vaccine documentation was entered into EPIC, it was noted that patient had received 2 prior doses of Pfizer vaccine on 02/13/21 and 03/10/21. Covering provider was notified and patient was informed of this medication error. Team debriefed and case manager and management notified.
Fever, Chills, Headache, Nausea, Photosensitivity
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 4 year old male patient who received a dose of Infanrix in the left arm (dose number not specified, lot AC14A009BA). The nurse reported that the dose of Infanrix was "for kindergarten." At an unspecified time following the administration of Infanrix, on 08 April 2005, the patient experienced injection site "swelling and redness" which extended "from shoulder to elbow". The patient was seen at a physician's office and was diagnosed with cellulitis. The patient was treated with cephalexin (Keflex). The nurse considered the injection site cellulitis to require clinical intervention. The injection site reaction resolved on an unspecified date before 25 April 2005. The nurse considered the injection site reaction to possibly be related to vaccination with Infanrix.
pt recv vax & devel 2" x 2" red swollen area noted @ site of inj;area warm to touch;mom phoned & brought pt in 24hr p/vax;